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stronger Survival of infants With Neuroblastoma Between 1979 and 2005: A file of the Italian Neuroblastoma Registry

Neuroblastoma, the most established extracranial childhood tumor,1 is characterised with the aid of various medical shows and different prognosis of its subsets. while in some patients the tumor is efficiently handled with surgery on my own,2 or may also regress spontaneously,three the possibility of remedy in babies older than 1 yr with metastatic ailment continues to be negative.1,four

youngsters the likelihood of survival for infants with neuroblastoma has improved over time, even the most appropriate published consequences don't parallel those obtained for most different childhood malignancies.5 Few experiences have documented this development by reporting tremendous series of patients diagnosed over a long duration.6–10 To provide more information, we reviewed the scientific and survival statistics of infants with neuroblastoma enrolled within the Italian Neuroblastoma Registry over a 27-12 months duration.

The Italian Neuroblastoma Registry became activated in 1979 and comprises all courses with any peripheral neuroblastic tumor (PNT, ie, neuroblastoma, ganglioneuroblastoma, and the benign ganglioneuroma), clinically determined on the associations taking part in the Italian Neuroblastoma group (ING).11 in the final decade greater than 90% of the anticipated Italian PNTs had been recruited via this community.12

Eligibility

little ones age 0 to 14 years clinically determined with malignant PNT between January 1979 and December 2005 were eligible. Older children have been excluded as a result of 14 years of age was the limit for admission to most Italian pediatric institutions. of two,439 registered patients, 223 had been ineligible due to prognosis of ganglioneuroma (n = 148), tumor histology aside from PNT (n = 33), age older than 14 years (n = 29), and inconsistent dates (n = 13), leaving 2,216 eligible. comply with-up changed into truncated at December 31, 2008.

Diagnostic Work-Up

Tumor analysis and disorder extension were described based on the foreign Neuroblastoma Staging gadget criteria.13 as a minimum two samples of bone marrow have been studied. Skeletal involvement changed into evaluated by means of roentgenograms, and considering 1985, by way of metaiodobenzylguanidine scintigraphy (specifically the use of 123-iodine) as well. MYCN gene become evaluated primarily via fluorescent in situ hybridization.14

treatment

patients had been treated by using ING protocols unless 1994,three,4,15–18 and by protocols of the international Society of Pediatric Oncology European Neuroblastoma community (SIOPEN) thereafter.2,19,31 All ING protocols were permitted through local institutional evaluate board, and their outlines are introduced in Appendix table A1 (online only). earlier than being enrolled and treated on their respective trials, patients or their guardians signed a consent form permitting using their medical and nongenetic information for scientific analysis applications. No different specific recommended consent turned into required for the purposes of this analyze.

patient Categorization

Three age groups were defined: 0 to 17, 12 to fifty nine, and ≥ 60 months. The primary tumor websites have been: thorax, adrenal gland, abdomen, neck plus pelvis, and different websites together with undetected, undetermined, and strange websites. four enrollment intervals have been centered: 1979 to 1984, 1985 to 1991, 1992 to 1998, and 1999 to 2005, based on the following: 1985, use of intensified chemotherapy18; 1992, adoption of foreign Neuroblastoma Staging system criteria13 and assessment of MYCN gene status14; and 1999, centrally reviewed pathology.

Statistical Analyses

Descriptive data had been pronounced as absolute frequencies and percentages. adjustments in frequencies of each and every variable over time were assessed via χ2 test for vogue; in case of more than two classes, frequencies in every class were also compared with these of the pool of the others. The χ2 test for heterogeneity changed into used to evaluate changes throughout agencies. ordinary survival (OS) changed into estimated by using Kaplan-Meier formula and alterations between agencies have been assessed by way of the log-rank examine. Survival estimate become referred to 10 years from diagnosis, aside from the last enrollment length, for which it became at 9 years. The median follow-up time became estimated by reverse Kaplan-Meier method.20

The combined effect of the distinctive possibility elements turned into evaluated with the aid of means of the Cox regression mannequin with time-stylish covariates through the use of a backward procedure. when you consider that information on the MYCN status of infants diagnosed before 1992 was unavailable, a nested mannequin turned into adopted in order to keep away from the exclusion of subjects clinically determined in the first two intervals.21

Deaths happening inside 30 days from analysis had been defined as early deaths. Deaths occurring after 5 years had been considered late deaths. The probability of late death was evaluated by further OS evaluation conditional to survival past the fifth yr from analysis. in this analysis, sufferers clinically determined after 1998 were excluded on account of the short comply with-up.

To estimate the chance of a 2d malignant neoplasm (SMN), the variety of person-years in danger for each affected person with neuroblastoma become calculated from the date of diagnosis except the date of remaining contact, demise, or analysis of an SMN, whichever passed off first. The anticipated number of cancers became bought the usage of age, intercourse, and length-specific incidence costs of the Italian inhabitants from the pool of the Italian cancer registries,22 and the corresponding standardized incidence ratios (SIRs) have been calculated for all invasive cancers mixed and chosen foreign Classification of diseases 9 classes. The exact Poisson distribution was used to calculate ninety five% CIs. All statistical exams were two sided and a P cost lessen than .05 changed into considered statistically big. All analyses have been carried out via the statistical kit Stata (edition 9.2, Stata agency, faculty Station, TX).

The demographic and medical features of the two,216 analyze sufferers, stratified via enrollment period, are listed in table 1. affected person accrual multiplied within the four durations from 348 (58/12 months) to 712 (102/yr). Male sex prevailed (fifty five.0% v 45.0%) with no changes over time (P = .730). infants age 0 to 17 months represented the largest neighborhood (forty five.6%), whereas babies age ≥ 60 months represented the smallest one (14.0%). patient distribution in the three age businesses changed over time (P = .008), because of a prevalence enhance of the youngest sufferers from 36.5% to forty eight.5% (P = .001) and a incidence lessen of sufferers in the 18- to 59-month age range from forty six.0% to 37.4% (P = .003). The simple site distribution changed over time (P = .023) because of the boost of adrenal tumors that rose from 35.9% to forty five.eight% (P = .002) and decrease of abdominal tumors that dropped from 42.5% to 33.9% (P = .004). in a similar fashion, the share of localized tumors elevated as compared to the disseminated ones from 44.3% to fifty three.four% (P = .001). As for stage distribution, an ascending fashion from 5.eight% to 23.2% became considered for stage 1 (P < .001), at the side of a lessen from 17.5% to 11.4% for stage 2 (P = .005), and from 48.0% to 39.0% for stage 4 (P = .003). No clear style turned into followed for both stage 3 or 4S.

Table

table 1. affected person qualities at analysis

table 1. patient qualities at analysis

attribute Enrollment period complete 1979-1984 1985-1991 1992-1998 1999-2005 P* No. % No. % No. % No. % No. % No. of patients 2,216 348 513 643 712 intercourse .730     Male 1,219 55.0 198 56.9275 53.6 357 55.five389 fifty four.6     feminine 997 45.0 150 forty three.1 238 forty six.four 286 44.five323 forty five.4 Male:female ratio 1.2 1.three 1.2 1.2 1.2 Age, months .008     0-17 1,010 45.6 127 36.5236 forty six.0 302 forty seven.0 345 forty eight.5     18-fifty nine 896 forty.four a hundred and sixty 46.0 219 42.7 251 39.0 266 37.4     ≥ 60 310 14.0 61 17.558 eleven.three ninety 14.0 one zero one 14.2 primary tumor web site .023     Adrenal 965 forty three.6 125 35.nine216 forty two.1 298 46.four 326 45.eight     abdomen 780 35.2 148 42.five189 36.8 202 31.4 241 33.9     Thorax 297 13.4 52 14.ninesixty eight 13.3 83 12.9ninety four 13.2     Neck/pelvis 132 6.0 14 four.0 30 5.945 7.0 43 6.0     different† forty two 1.9nine2.6 10 2.0 15 2.three eight 1.1 disorder extension .001     Localized 1,097 forty nine.five154 forty four.three 238 46.four 325 50.five380 53.4     Disseminated 1,119 50.five194 55.8 275 53.6 318 49.five332 46.6 INSS stage < .001     1 372 sixteen.8 20 5.8 60 eleven.7 127 19.eight 165 23.2     2 301 13.6 sixty one 17.5seventy five 14.6 eighty four 13.1 81 eleven.four     3 424 19.1 seventy three 21.0 103 20.1 114 17.7 134 18.eight     four 929 forty one.9167 48.0 225 43.nine259 forty.3 278 39.0     4S a hundred ninety eight.6 27 7.8 50 9.eight fifty nine 9.2 54 7.6

affected person distribution via stage and age, simple web site and age, and first web page and stage is reported in figure 1. among the many youngest patients, degrees had been in a similar way represented, while stage four predominated in the subsequent age tiers (P < .001, each including and aside from stage 4S from evaluation; information not shown). Adrenal and stomach had been the most regular websites in all age stages with identical proportions, other than youngest little ones who had extra adrenal than stomach tumors (P = .001). at last, there was a clear affiliation between simple site and stage, with adrenal prevailing in stages 1 and 4S, adrenal and abdomen in ranges three and 4, and thorax in stage 2 (P < .001).

The outcomes of biologic experiences by means of stage at diagnosis are depicted in Appendix desk A2 (on-line simplest). improved values had been recorded in 36.four% of patients for lactate dehydrogenase (LDH), forty two.7% for ferritin, and in 68.eight% for vanillylmandelic acid (VMA). MYCN gene was amplified in 15.1% of validated tumors. Stage 4 children had the maximum share of expanded laboratory values for all markers, other than VMA which was most often increased in stage 4S (P < .001 for all). most effective 681 patients (30.7%) had valid statistics for all of the biologic markers. toddlers with MYCN-amplified tumors had vastly more commonly improved LDH and ferritin values and common VMA tiers as in comparison to these with average MYCN status (Appendix desk A3 on-line most effective).

medical route

Median patient follow-up turned into 7.0 years (range, 0 days to 28 years). a complete of 898 sufferers (40.5%) developed sickness development or relapse, 19 (0.9%) developed an SMN, and two (0.1%) developed myelodysplasia. SMN included strong tumors in eleven sufferers (thyroid carcinoma in eight, schwannoma in two, histiocytoma in a single), and hematologic malignancies in eight (acute myeloid leukemia in three, continual myeloid leukemia, and non-Hodgkin's lymphoma in two patients each, and Hodgkin's disorder in one; desk 2). Median interval between diagnoses of neuroblastoma and SMN changed into 11.three years (range, 0.7 to 18.four years). The cumulative possibility of constructing an SMN at two decades after diagnosis was 7.1% (ninety five% CI, four.1% to 12.1%). in comparison with the Italian inhabitants of the identical age and intercourse, patients with neuroblastoma had an 8.four-fold multiplied possibility of setting up an SMN (SIR, eight.4; ninety five% CI, 5.1 to 13.2). SIR changed into 131.7 (ninety five% CI, 56.9 to 259.5) for thyroid cancers, 52.7 (ninety five% CI, 17.1 to 122.9) for myeloid leukemias, 24.0 (95% CI, 5.0 to 70.2) for smooth tissue sarcomas, and 12.5 (ninety five% CI, 2.6 to 36.4) for lymphomas.

Table

table 2. details of patients Who Developed a 2nd Malignant Neoplasm (n = 21)

table 2. particulars of patients Who Developed a 2d Malignant Neoplasm (n = 21)

patient No. prognosis of Neuroblastoma therapy 2nd Neoplasm Interval (months) Survival (months) Age (months) Date levelCT MIBG Ext RT TBI 1174 37 November 1994 1 No No No No T-lymphoblastic non-Hodgkin's lymphoma 177 156* eleven 90 December 1984 2A sureNo definiteNo Thyroid carcinoma 185 228* 95March 1980 2B convincedNo No No chronic myeloid leukemia 161 237* 384 26 December 1986 three sureconvincedNo No Schwannoma 179 185 701 12 June 1989 3 certainNo No No Thyroid carcinoma 201 188* 852 47 June 1991 3 convincedsureNo No Fibrous angiomatoid histiocytoma 87 146* 878 37 November 1991 three suredefiniteNo No Schwannoma 87 108† 549 forty one February 1985 four yessureNo sureAcute myeloid leukemia 136 169 592 32 November 1986 four certainNo No convincedThyroid carcinoma 221 206* 688 46 July 1989 4 sureNo No convincedAcute myeloid leukemia eleven 14 771 71 February 1990 4 yesNo No convincedThyroid carcinoma 154 122* 779 70 April 1990 four yesNo No definiteThyroid carcinoma 104 164* 798 21 July 1990 four yesNo No sureThyroid carcinoma 156 201* 797 forty August 1990 4 sureNo No definiteThyroid carcinoma 184 162* 1007 47 April 1993 4 convincedNo No No Hodgkin's disease 124 128* 1038 54 July 1993 four certaincertainNo No Acute myeloid leukemia 28 57 1440 70 April 1997 4 surecertainNo No Myelodysplasia 96 127* 1664 42 April 1999 four yesNo No No Myelodysplasia 25 33 1817 25 August 2000 four yesNo No No chronic myeloid leukemia 14 19 610 10 June 1987 4S sureNo No yesThyroid carcinoma 181 199* 2601 1 June 2005 4S convincedNo No No Anaplastic non-Hodgkin's lymphoma nine29*

Survival

a total of 858 patients (38.7%) died: 779 (90.8%) of disorder development or relapse, seventy one (8.three%) of remedy-connected toxicity, six (0.7%) of SMN, and two (0.2%) after surgery unrelated to neuroblastoma. The final neuroblastoma-related death happened at 12.9 years from analysis. Ten-year OS of the complete cohort changed into 55.3% (ninety five% CI, 53.0% to fifty seven.6%), and became fifty nine.four% (ninety five% CI, fifty seven.2% to 61.6%) at 5 years, and 53.9% (ninety five% CI, fifty one.4% to 56.four%) at 20 years. a significant increase in survival from 34.9% to sixty five.0% (P < .001) passed off over the four enrollment intervals (table 3). The development was specially evident when evaluating the first with the next durations (Fig 2A). OS became drastically worse for men than females (P = .047). Age, fundamental site, and stage also strongly correlated with OS (P < .001 for all; table three; Figs 2B to C). The youngest infants fared drastically more desirable when compared with the following age degrees (P < .001).

Table

table 3. Ten-year typical Survival through Enrollment length and medical and organic factors

table 3. Ten-year standard Survival through Enrollment period and medical and biological factors

Parameter No. 10-yr overall Survival (%) ninety five% CI* P Enrollment period < .001     1979-1984 348 34.929.7 to 40.2     1985-1991 513 fifty two.6 forty seven.9 to 57.0     1992-1998 643 59.1 fifty four.8 to sixty three.2     1999-2005* 712 65.0 60.1 to 69.4 intercourse .047     Male 1,219 52.4 49.2 to 55.6     feminine 997 fifty eight.eight fifty five.3 to sixty two.2 Age at diagnosis, months < .001     0-17 1,010 eighty.6 seventy seven.8 to 83.1     18-fifty nine 896 36.nine33.three to forty.four     ≥ 60 310 27.7 21.6 to 34.0 Tumor simple website < .001     Adrenal 965 forty seven.nine44.2 to 51.5     stomach 780 fifty two.548.6 to 56.three     Thorax 297 seventy nine.6 73.7 to 84.4     Pelvis/neck 132 81.four seventy two.3 to 87.7     other 42 33.2 17.7 to 49.6 Stage < .001     1 372 96.2 ninety three.1 to 97.9     2 301 88.6 eighty three.9 to ninety two.0     three 424 66.7 61.3 to 71.5     4 929 22.four 19.5 to 25.5     4S 190 77.four 70.0 to 83.2 Serum LDH (482 lacking) < .001     average 1102 70.fivesixty seven.2 to seventy three.5     improved 632 30.five26.5 to 34.5 Serum ferritin (802 missing) < .001     normal 810 73.four sixty nine.7 to seventy six.7     expanded 604 33.4 29.2 to 37.7 Urine VMA (396 lacking) < .001     general 568 64.0 fifty nine.four to sixty eight.three     increased 1252 50.nineforty seven.eight to fifty three.9 MYCN gene (1,133 lacking) < .001     regular 920 69.2 sixty five.1 to seventy three.0     Amplified 163 28.0 20.7 to 35.7

sufferers with thoracic, cervical, or pelvic primaries had the stronger results whereas the 42 with different websites (36 of whom had metastatic ailment) had the worst (P < .001).

Stage 1 and a pair of sufferers fared very smartly (OS, 96.2% and 88.6%), whereas stage 3 patients had a less favorable result (OS, sixty six.7%). Stage four sufferers had a grim outcomes (OS, 22.4%), while stage 4S had an OS of seventy seven.4% (desk three; Fig 2B).

The OS of the complete cohort relating to stage and enrollment length is depicted in determine three. Stage 1 patients diagnosed within the first duration fared worse than those diagnosed within the subsequent durations (eighty five.0% v ninety four.2%, 100%, and 95.1%; P = .007; Fig 3A). Survival of stage three sufferers better from 33.three% to 88.5% (P < .001; Fig 3C). a transparent OS growth for stage 4 become recorded through evaluating the first with the subsequent enrollment intervals (6.7% v 23%, 26%, and 29%; P < .001; Fig 3D). No changes over time have been recorded for either stage 2 or 4S patients (Fig 3B and 3E). OS become greatly worse (P < .001) for patients with increased LDH (30.5% v 70.5%) and ferritin (33.four% v seventy three.4%), urinary VMA (50.9% v 64.0%), and irregular MYCN gene (28.0% v sixty nine.2%).

When the mixed impact of prognostic factors changed into assessed with the aid of Cox regression model, handiest 1,209 courses had valid facts for each variable. As pronounced in Appendix desk A4 (on-line only), all analyzed risk elements except intercourse and VMA had been greatly associated with survival. for most risk elements, the effect turned into much less evident, as proven via the lower hazard ratio values when in comparison with these of the univariable analysis.

Early Deaths

Early deaths (n = 41; 4.8%) have been dispensed equally within the four enrollment periods (P = .429), but in another way throughout ranges and ages (P < .001 for both; Appendix table A5, online only). there have been two early deaths in stage 1 and four in stage 2, all of which have been surgery connected, which represented 18.2% and 12.9% of the deaths that occurred in these ranges. The percentage of early deaths for stage three and four patients become lower (4.1% and a couple of.6%) and highest for stage 4S babies (34.2%). Early deaths were extra regular in patients age 0 to 17 months than in the subsequent age degrees (14.three% v 3.0% and zero.5%; P < .001).

Late Deaths

Late deaths (n = fifty five; 6.four%) had been tumor connected in fifty three patients and SMN linked in two sufferers. handiest 5 late deaths came about among babies clinically determined within the first enrollment duration, as will also be considered by using the well-nigh horizontal plot after the fifth yr from analysis (Fig 2A). little ones clinically determined in the following intervals had stronger OS, but endured to die after the fifth yr at a rate that became vastly bigger in comparison with infants diagnosed in the past period (P = .042). If stage at diagnosis become taken into consideration, survival conditional for having survived longer than 5 years turned into enormously reduce for stage four sufferers (seventy seven.7%) as in comparison with other tiers.

results of treating neuroblastoma have certainly enhanced, as survival quotes have accelerated from under 25% within the 1970s,23,24 to more than forty% within the Eighties,6–8 and to 50% to 60% in the Nineteen Nineties.9,10 Our facts supply confirmation of this development. patient enrollment accelerated remarkably along the study durations, as an expression of the starting to be adhesion of the Italian pediatric oncology institutions to the countrywide protocols. Some impact might also be because of the about 2% annual raise in neuroblastoma incidence in Italy over time.25 A slight occurrence of male intercourse changed into recorded, confirming the observations from population-primarily based registries.5 Enrollment of the youngest sufferers extended remarkably over time. This increase might reflect progressively better clinical consideration mixed with the extra common use of perinatal ultrasound.26 The adrenal and abdominal simple tumor sites confirmed an opposite style, possibly because of the greater imaging recommendations, which can be capable of improved outline the beginning of a tumor.

typical, the ratio between localized and disseminated tumors become near 1. besides the fact that children, the percent of localized tumors improved over time, and in the ultimate two a long time it overtook that of disseminated tumors. The incidence of stage 4 patients has diminished somewhat, while that of stage 4S has remained regular at round eight%, might be because this clinical pattern is much less susceptible to enrollment adaptations.

Deaths took place in 38.7% of patients for a ten-yr OS of 55.three%. female sufferers fared more suitable, as already outlined.7,23 The speculation of Pritchard et al27 that the change in outcome depends upon the superior percentage of stage 4 male patients is Checked by means of our records, wherein stage 4 adult males prevailed (fifty nine.2% v 40.8%). really, in the multivariable evaluation the sex effect disappeared.

OS superior remarkably over time, and become peculiarly evident when comparing the first enrollment period with right here ones. This growth is probably the effect of mixing intensified chemotherapy with refined supportive measures which grew to be obtainable within the mid- Eighties. youngsters, these cures did not nullify the poor have an impact on of any biologic risk factor.

As pronounced through others,6–11,19 OS was vastly better in the youngest age group, and in infants with stage 1, 2, and 4S disorder, added-stomach basic tumors, usual biochemical values, and typical MYCN gene. The possible affect of Shimada histology on effect changed into now not assessed considering that central pathology assessment turned into restrained to the final part of the examine. however, in no cases the histologic subtype become taken into account for possibility stratification.

outcomes did not enrich over time in any of the levels. for instance, no clear growth turned into noticed for stage 2 and 4S. On the contrary, stage 3 showed a astonishing growth from 33.3% to 88.5%. since radiation therapy turned into given to a minority of those sufferers, the recorded alterations could be attributed to chemotherapy intensification, which became operative after 1985, and become made feasible by way of the common use of indwelling catheters. As reported by using Bagatell et al28 the results have perhaps improved even further with the aid of treating sufferers with an abnormal MYCN gene replica quantity very aggressively. The contribution of a greater effective surgical strategy to those tumors is below investigation.

The improvement of intensified chemotherapy was seen for stage four sufferers as neatly. Their OS increased from 6.7% of the first enrollment duration to 26.0% within the 2nd. sadly adequate, and in contrast to stage three disease, no additional growth became recorded within the subsequent periods. We might also anticipate that chemotherapy is close to ending its expertise for this tumor stage, consequently making it mandatory to discover new therapeutic processes.1,29

amongst 858 deaths, forty one came about inside the first 30 days from prognosis. Early deaths had been equally distributed alongside enrollment durations. Stage 1 and a pair of sufferers suffered a excessive proportion of early deaths that were all surgical procedure linked. This truth emphasizes the value of standardizing presurgical tumor stories to accurately predict surgical dangers. choosing picture-defined possibility factors may additionally contribute to cutting back surgery-related mortality.30 Early deaths passed off in approximately one third of toddlers with stage 4S ailment and the incidence did not lower over time. These younger children always die because the outcomes of overwhelming sickness, for which no efficient remedy has been discovered yet.5,31 Late deaths occurred more often in older and adolescent little ones, hence confirming the indolent path of the disease at these a long time.eleven They were additionally more general in children clinically determined greater lately, probably because of incontrovertible fact that besides the fact that children contemporary therapeutic remedies have more suitable survival, they nevertheless fail to eradicate the tumor in some patients.

Twenty-one sufferers developed either an SMN or myelodysplasia after a median interval of eleven years after preliminary prognosis, leading to an SIR of 8.forty five, which is better than the 5.9 pronounced in Surveillance, Epidemiology, and end consequences records.32 Thyroid melanoma become essentially the most conventional SMN (SIR, 131), tons greater than in the Surveillance, Epidemiology, and conclusion results cohort. This change could be involving a greater aggressive remedy, in particular for patients who received megatherapy associated to total-physique irradiation, and to the policy of performing well-known ultrasonographic screening all the way through follow-up. The latter has possibly allowed us to notice some small thyroid nodules that could have been overlooked through scientific examination by myself. at last, our statistics ascertain our outdated observation33 denying an oncogenic function of therapeutic [131I] metaiodobenzylguanidine, given that not one of the sufferers who developed thyroid cancer received this medicine.

Myeloid leukemia or myelodysplasia were seemingly secondary to the aggregate of alkylating agents and epipodophyllotoxin-primarily based therapeutic regimens, and, in some cases, to radiotherapy. Of observe, a T-lymphoblastic lymphoma happened in a affected person handled with the aid of surgery by myself, and an anaplastic lymphoma kynase–positive lymphoma developed in a stage 4S patient handled with handiest two lessons of chemotherapy. In these topics, a genetic predisposition can be regarded as a possible chance component.34

In conclusion, our statistics confirm that greater outcomes has been completed in neuroblastoma, principally in patients offering with unresectable nonmetastatic ailment. The expanding number of lengthy-time period survivors bears a significant risk of constructing an SMN.

© 2010 by using American Society of clinical Oncology

Authors' disclosures of knowledge conflicts of pastime and creator contributions are discovered on the conclusion of this text.

AUTHORS' DISCLOSURES OF competencies CONFLICTS OF hobby

The creator(s) indicated no potential conflicts of hobby.

concept and design: Riccardo Haupt, Alberto Garaventa, Claudio Gambini, Stefano Parodi, Anna Rita Gigliotti, Guido Pastore, Bruno De Bernardi

Provision of examine substances or sufferers: Riccardo Haupt, Alberto Garaventa, Fiorina Casale, Elisabetta Viscardi, Maurizio Bianchi, Arcangelo Prete, Alessandro Jenkner, Roberto Luksch, Andrea Di Cataldo, Claudio Favre, Paolo D'Angelo, Giulio Andrea Zanazzo, Giampaolo Arcamone, Gian Carlo Izzi, Guido Pastore, Bruno De Bernardi

collection and assembly of statistics: Riccardo Haupt, Stefano Parodi, Giuliana Cangemi, Elisabetta Viscardi, Guido Pastore, Bruno De Bernardi

information analysis and interpretation: Riccardo Haupt, Claudio Gambini, Stefano Parodi, Giuliana Cangemi, Fiorina Casale, Elisabetta Viscardi, Maurizio Bianchi, Arcangelo Prete, Alessandro Jenkner, Roberto Luksch, Andrea Di Cataldo, Claudio Favre, Paolo D'Angelo, Giulio Andrea Zanazzo, Giampaolo Arcamone, Gian Carlo Izzi, Anna Rita Gigliotti, Guido Pastore, Bruno De Bernardi

Manuscript writing: Riccardo Haupt, Alberto Garaventa, Claudio Gambini, Stefano Parodi, Giuliana Cangemi, Guido Pastore, Bruno De Bernardi

last approval of manuscript: Riccardo Haupt, Alberto Garaventa, Claudio Gambini, Stefano Parodi, Giuliana Cangemi, Fiorina Casale, Elisabetta Viscardi, Maurizio Bianchi, Arcangelo Prete, Alessandro Jenkner, Roberto Luksch, Andrea Di Cataldo, Claudio Favre, Paolo D'Angelo, Giulio Andrea Zanazzo, Giampaolo Arcamone, Gian Carlo Izzi, Anna Rita Gigliotti, Guido Pastore, Bruno De Bernardi

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M Shemper, TL Smith : A word on satisfactory follow-up in reviews of failure time manage Clin Trials 17: 343– 346,1996 Crossref, Medline, Google pupil21. k Leffondré, M Abrahamowicz, J Siemyaticky , etal : Modeling smoking heritage: A comparison of distinct approaches Am J Epidemiol 156: 813– 823,2002 Crossref, Medline, Google student22. Associazione Italiana Registri Tumori http://registri-tumori.it Google student23. LM Kinnier-Wilson, GJ Draper : Neuroblastoma, its herbal historical past and prognosis: A study of 487 situations BMJ three: 301– 307,1974 Crossref, Medline, Google pupil24. JM Zucker : Retrospective study of 462 neuroblastomas treated between 1950 and 1970 Maandschr Kindergeneesk English 42: 369– 385,1974 Google student25. 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We thank Lisa Baracco for secretarial guidance; Valerie Perricone for revising the text; Barbara Galleni and Giovanni Erminio for statistics management; Katia Mazzocco, Raffaella Defferrari, and Francesca Negri for biologic studies; and Eugenio Paci for providing statistics on cancer incidence within the Italian inhabitants. This examine became supported in part by means of the Italian Neuroblastoma basis and by Italian Ministry of health Ricerca Finalizzata, Bando Oncologia 2006. S.P. is a recipient of a grant offered by using the Italian Neuroblastoma foundation.

Table

desk A1. summary of First-Line Italian Neuroblastoma group Protocols

desk A1. abstract of First-Line Italian Neuroblastoma neighborhood Protocols

levelduration of diagnosis 1979-1984 1985-1991 1992-1998 1999-2005 1 surgical procedure surgery surgery surgical procedure 2 surgery + common-dose chemotherapy ± radiation cureSurgery + ordinary-dose chemotherapy Low-possibility*: surgery MYCN not amplified: surgical procedure high-possibility: surgery + ordinary-dose chemotherapy MYCN amplified: surgical procedure + high-dose chemotherapy 3 common-dose chemotherapy + surgery + average-dose chemotherapy + radiation cureexcessive-dose chemotherapy + surgical procedure + high-dose chemotherapy ± [131I] metaiodobenzylguanidine Low-possibility†: common-dose chemotherapy + surgery MYCN not amplified: normal-dose chemotherapy + surgical procedure excessive-risk: excessive-dose chemotherapy + surgical procedure ± excessive-dose chemotherapy ± [131I] metaiodobenzylguanidine MYCN amplified: as stage 4 4 ordinary-dose chemotherapy + surgery + average-dose chemotherapy + radiation treatmentexcessive-dose chemotherapy + surgery + high-dose chemotherapy with megatherapy followed with the aid of peripheral- blood stem-mobilephone rescue (complete physique irradiation) excessive-dose chemotherapy + surgical procedure + high-dose chemotherapy with megatherapy adopted with the aid of peripheral-blood stem-telephone rescue excessive-dose chemotherapy + surgery + usual-dose chemotherapy with megatherapy adopted with the aid of peripheral-blood stem-cell rescue + radiation cure4S general-dose chemotherapy + surgery Wait and spot Wait and notice Wait and notice Table

desk A2. Distribution of Values of biological Markers via Stage

desk A2. Distribution of Values of biological Markers through Stage

Parameter complete Stage P 1 2 three four 4S No. % No. % No. % No. % No. % No. % Serum LDH (482 missing) < .001     normal 1,102 63.6 244 89.1 191 88.four 246 72.1 305 40.7 116 seventy five.8     expanded 632 36.4 30 10.nine25 11.6 95 27.nine445 fifty nine.three 37 24.2 Serum ferritin (802 missing) < .001     common 810 57.three 157 seventy four.four 134 82.2 202 73.2 234 37.2 83 61.5     expanded 604 forty two.7 54 25.6 29 17.eight 74 26.8 395 62.8 fifty two 38.5 Urine VMA (396 missing) < .001     ordinary 568 31.2 166 59.three 116 47.7 109 30.2 159 20.518 eleven.three     multiplied 1,252 sixty eight.8 114 40.7 127 52.three 252 sixty nine.eight 617 seventy nine.5142 88.7 MYCN gene (1,133 missing) < .001     regular 920 84.nine232 ninety five.nine132 96.four 180 85.three 30073.2 76 91.6     Amplified 163 15.1 10 four.1 53.6 31 14.7 one hundred ten 26.eight 7 eight.four Table

desk A3. association Between biological Prognostic Markers

desk A3. affiliation Between biological Prognostic Markers

Marker Ferritin VMA MYCN normal expanded P general multiplied P normal Amplified P No. % No. % No. % No. % No. % No. % LDH < .001 .568 < .001     usual 594 75.6 244 forty one.6 313 64.0 665 sixty two.5 557 70.2 22 15.6     accelerated 192 24.4 342 58.4 176 36.0 399 37.5 237 29.nine119 84.four Ferritin — .030 < .001     normal — — — — 252 sixty one.nine486 fifty five.5 407 61.8 46 37.1     expanded — — — — 155 38.1 390 forty four.5 252 38.2 seventy eight 62.9 VMA — — < .001     average — — — — — — — — 240 32.8 sixty eight 51.5     extended — — — — — — — — 491 sixty seven.2 64 forty eight.5 Table

table A4. Cox model for Survival evaluation of toddlers With Neuroblastoma

table A4. Cox model for Survival analysis of little ones With Neuroblastoma

Parameter Univariable analysis Multivariable analysis* HR ninety five% CI P HR 95% CI P Enrollment length < .001 < .001     1979-1984 1 (ref) — 1 (ref) —     1985-1991 0.55 0.45 to 0.sixty six 0.33 0.23 to 0.46     1992-1998 0.forty two 0.35 to 0.fifty one 0.20 0.14 to 0.28     1999-2005* 0.33 0.27 to 0.forty one 0.sixteen 0.eleven to 0.24 sex .047 .961†     Male 1 (ref) — 1 (ref) —     female 0.87 0.76 to 0.99 0.ninety nine 0.82 to 1.2 Age at diagnosis, months‡ < .001 < .001     0-17 1 (ref) — 1 (ref) —     18-36 4.1 3.four to 4.9 1.nine1.6 to 2.3     ≥ 60 four.1 three.3 to five.1 2.1 1.7 to 2.four primary web site < .001 .049     Adrenal 1 (ref) — 1 (ref) —     stomach 0.96 0.eighty three to 1.1 0.ninety two 0.76 to 1.1     Thorax 0.31 0.23 to 0.forty two 0.sixty six 0.43 to 1.0     Pelvis/neck 0.28 0.18 to 0.44 0.fifty five 0.28 to 1.1     different 1.51.0 to 2.four 1.90.89 to 4.1 Stage < .001 < .001     1 1 (ref) — 1 (ref) —     2 3.three 1.6 to six.5 6.three 1.eight to 21.4     three eleven.1 6.0 to twenty.6 12.1 three.8 to 38.eight     four 35.five19.5 to 64.4 21.1 6.7 to 66.four     4S 6.ninethree.5 to 13.5 16.ninefour.9 to 58.1 Serum LDH < .001 < .001     general 1 (ref) — 1 (ref) —     extended three.6 three.1 to 4.2 1.8 1.four to 2.2 Serum ferritin < .001 < .001     common 1 (ref) — 1 (ref) —     improved 3.4 2.9 to four.1 1.four 1.2 to 1.eight Urine VMA < .001 .164†     standard 1 (ref) — 1 (ref) —     elevated 1.4 1.2 to 1.7 0.85 0.sixty eight to 1.1 MYCN gene§ < .001 < .001     usual 1 (ref) — 1 (ref) —     Amplified         1992-1998 4.ninethree.9 to six.2 2.2 1.5 to three.1         1999-2005 four.93.9 to 6.2 1.7 1.2 to 2.6 Table

table A5. Distribution of Early Deaths with the aid of Stage, Enrollment period, and Age at prognosis

table A5. Distribution of Early Deaths through Stage, Enrollment period, and Age at prognosis

Parameter total No. of Deaths Early Deaths No. % P Enrollment length .429     1979-1984 210 eight 3.8     1985-1991 228 10 four.4     1992-1998 239 16 6.7     1999-2005 181 7 three.9 INSS stage < .001     1 eleven 2 18.2     2 31 4 12.9     three 121 54.1     four 657 17 2.6     4S 38 13 34.2 Age, months < .001     0-17 a hundred seventy five 25 14.three     18-59 498 15 3.0     ≥ 60 185 1 0.5

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