Chemotherapy with or without surgery

Symptomatic disease. The chemotherapy regimen consists of carboplatin, cyclophosphamide, doxorubicin, and etoposide. The cumulative chemotherapy dose of each agent is kept low to minimize long-term effects.[3]

Unresectable progressive disease after surgery.

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3]

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3]

Stage 1:

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3] › Stage 1:

Patients with stage 1 disease achieved a 5-year EFS rate of 93% and a 5-year OS rate of 99%.

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3]

Stage 2A and 2B:

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3] › Stage 2A and 2B:

Asymptomatic patients with stage 2A and 2B disease (n = 306) who were observed after initial operation had a 5-year EFS rate of 87% and an OS rate of 96%.

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3] › Stage 2A and 2B:

The EFS rate was significantly better for patients with stage 2A than for patients with stage 2B neuroblastoma (92% vs. 85%; P = .0321), but OS did not differ significantly (98% vs. 96%; P = .2867).

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3] › Stage 2A and 2B:

The primary study objective (to achieve a 3-year OS rate of 95% for asymptomatic patients with stage 2A and 2B disease) was met.

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3] › Stage 2A and 2B:

Patients with stage 2B disease had a lower EFS and OS if they had an unfavorable histology (EFS rate, 72%; OS rate, 86%) or diploid tumors (EFS rate, 75%; OS rate, 84%) or were older than 18 months.

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3] › Stage 2A and 2B:

Outcomes for patients with stage 2B, diploid tumors, and unfavorable histology were particularly poor (EFS rate, 54%; OS rate, 70%), with no survivors among the few patients who had additional 1p loss of heterozygosity.

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3] › Stage 2A and 2B:

All the deaths occurred in children older than 18 months.

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3]

Outcome of asymptomatic patients at diagnosis who were observed after initial operation and patients treated with chemotherapy postoperatively: Of the initial 915 patients, 800 were asymptomatic at diagnosis and observed after their initial operations. Within this group, 11% of patients experienced recurrent or progressive disease. Of the 115 patients who underwent surgery followed by immediate chemotherapy (median, 4 cycles; range, 1–8 cycles), 81% of the patients had a very good partial response or better. After chemotherapy, 10% of the patients had disease recurrence or progression.

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3] › Outcome of asymptomatic patients at diagnosis who were observed after initial operation and patients treated with chemotherapy postoperatively: Of the initial 915 patients, 800 were asymptomatic at diagnosis and observed after their initial operations. Within this group, 11% of patients experienced recurrent or progressive disease. Of the 115 patients who underwent surgery followed by immediate chemotherapy (median, 4 cycles; range, 1–8 cycles), 81% of the patients had a very good partial response or better. After chemotherapy, 10% of the patients had disease recurrence or progression.

For patients treated with surgery alone, the 5-year EFS rate was 89%, and the OS estimate was 97%.

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3] › Outcome of asymptomatic patients at diagnosis who were observed after initial operation and patients treated with chemotherapy postoperatively: Of the initial 915 patients, 800 were asymptomatic at diagnosis and observed after their initial operations. Within this group, 11% of patients experienced recurrent or progressive disease. Of the 115 patients who underwent surgery followed by immediate chemotherapy (median, 4 cycles; range, 1–8 cycles), 81% of the patients had a very good partial response or better. After chemotherapy, 10% of the patients had disease recurrence or progression.

For patients treated with surgery and immediate chemotherapy, the 5-year EFS rate was 91%, and the OS estimate was 98%.

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3]

MYCN amplification: The impact of MYCN-amplified tumors was analyzed in patients with stage 1 disease.

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3] › MYCN amplification: The impact of MYCN-amplified tumors was analyzed in patients with stage 1 disease.

For patients with MYCN-nonamplified tumors, the 5-year EFS rate was 93%, and the OS rate was 99%.

The COG-P9641 study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 915 infants and children with INSS stage 2A and 2B disease underwent an initial operation to obtain tissue for diagnosis and biology studies and for maximal safe primary tumor resection. Chemotherapy was reserved for patients with, or at risk of, symptomatic disease, with less than 50% tumor resection at diagnosis, or with unresectable progressive disease after surgery alone.[3] › MYCN amplification: The impact of MYCN-amplified tumors was analyzed in patients with stage 1 disease.

For patients with MYCN-amplified tumors, the 5-year EFS rate was 70% (P = .0042), and the OS rate was 80% (P < .001).