Analysis of Prognostic Factors in Patients With Nonmetastatic Rhabdomyosarcoma Treated on Intergroup Rhabdomyosarcoma Studies III and IV: The Children's Oncology Group

2006 ◽  
Vol 24 (24) ◽  
pp. 3844-3851 ◽  
Author(s):  
Jane L. Meza ◽  
James Anderson ◽  
Alberto S. Pappo ◽  
William H. Meyer
Keyword(s):  
Regional Lymph Node ◽  
Oncology Group ◽  
Anatomic Site ◽  
Primary Tumors ◽  
Undifferentiated Sarcoma ◽  
Group Iii ◽  
Disease Characteristics ◽  
Group I ◽  
Node Disease ◽  
Stage 1

Purpose The outcome for localized rhabdomyosarcoma (RMS) or undifferentiated sarcoma (UDS) is affected by age, histology, primary anatomic site, extent of disease, and therapy. Patients and Methods We evaluated patient and disease characteristics for their ability to predict outcome for patients with nonmetastatic RMS or UDS treated on Intergroup Rhabdomyosarcoma Study (IRS) -III (1984 to 1991) or IRS-IV (1991 to 1997). Results The estimated 5-year failure-free survival (FFS) rate was 90% for patients with embryonal RMS (ERMS) stage 1, group I or IIa; stage 2, group I; or group III orbit. The estimated 5-year FFS rate was 87% for patients with ERMS stage 1, group IIb or IIc; stage 1, group III nonorbit; stage 2, group II; and stage 3, group I or II; and 73% for patients with ERMS stage 2 or 3, group III. The estimated 5-year FFS rate was poor for patients with stage 2 or 3, group III ERMS with invasive (T2) tumors who were age younger than 1 year or 10 years or older (56%) and patients with stage 2 or 3, group III extremity primary tumors (43%). Overall, outcomes for patients with alveolar RMS (ARMS) or UDS were worse than for patients with ERMS. However, the 5-year FFS rate was good for patients with ARMS/UDS at favorable sites with group I or II (80%) or group III (76%) disease. The FFS rate was poorer for patients with ARMS/UDS at unfavorable sites with group I or II (66%) or group III (45%) disease. The estimated 5-year FFS rate was 31% for patients with group III ARMS/UDS at unfavorable sites with regional lymph node disease, which is similar to metastatic RMS. Conclusion Patient and disease characteristics identify distinct subsets with different outcomes, allowing the Soft Tissue Sarcoma Committee of the Children's Oncology Group to refine risk-adapted therapy assignment.

scholarly journals Vincristine, Actinomycin, and Cyclophosphamide Compared With Vincristine, Actinomycin, and Cyclophosphamide Alternating With Vincristine, Topotecan, and Cyclophosphamide for Intermediate-Risk Rhabdomyosarcoma: Children's Oncology Group Study D9803

2009 ◽  
Vol 27 (31) ◽  
pp. 5182-5188 ◽  
Author(s):  
Carola A.S. Arndt ◽  
Julie A. Stoner ◽  
Douglas S. Hawkins ◽  
David A. Rodeberg ◽  
Andrea A. Hayes-Jordan ◽  
...  
Keyword(s):  
Local Therapy ◽  
Risk Groups ◽  
Intracranial Extension ◽  
Primary Study ◽  
Intermediate Risk ◽  
Undifferentiated Sarcoma ◽  
Group Iii ◽  
Group I ◽  
Α Level ◽  
Stage 1

PurposeThe purpose of this study was to compare the outcome of patients with intermediate-risk rhabdomyosarcoma (RMS) treated with standard VAC (vincristine, dactinomycin, and cyclophosphamide) chemotherapy to that of patients treated with VAC alternating with vincristine, topotecan, and cyclophosphamide (VAC/VTC).Patients and MethodsPatients were randomly assigned to 39 weeks of VAC versus VAC/VTC; local therapy began after week 12. Patients with parameningeal RMS with intracranial extension (PME) were treated with VAC and immediate x-ray therapy. The primary study end point was failure-free survival (FFS). The study was designed with 80% power (5% two-sided α level) to detect an increase in 5-year FFS from 64% to 75% with VAC/VTC.ResultsA total of 617 eligible patients were entered onto the study: 264 were randomly assigned to VAC and 252 to VAC/VTC; 101 PME patients were nonrandomly treated with VAC. Treatment strata were embryonal RMS, stage 2/3, group III (33%); embryonal RMS, group IV, less than age 10 years (7%); alveolar RMS or undifferentiated sarcoma (UDS), stage 1 or group I (17%); alveolar RMS/UDS (27%); and PME (16%). At a median follow-up of 4.3 years, 4-year FFS was 73% with VAC and 68% with VAC/VTC (P = .3). There was no difference in effect of VAC versus VAC/VTC across risk groups. The frequency of second malignancies was similar between the two treatment groups.ConclusionFor intermediate-risk RMS, VAC/VTC does not significantly improve FFS compared with VAC.

scholarly journals Shorter-Duration Therapy Using Vincristine, Dactinomycin, and Lower-Dose Cyclophosphamide With or Without Radiotherapy for Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma: A Report From the Soft Tissue Sarcoma Committee of the Children's Oncology Group

2014 ◽  
Vol 32 (31) ◽  
pp. 3547-3552 ◽  
Author(s):  
David O. Walterhouse ◽  
Alberto S. Pappo ◽  
Jane L. Meza ◽  
John C. Breneman ◽  
Andrea A. Hayes-Jordan ◽  
...  
Keyword(s):  
Residual Disease ◽  
Incidence Rates ◽  
Low Risk ◽  
Newly Diagnosed ◽  
Oncology Group ◽  
Group Iii ◽  
Group I ◽  
Risk Patients ◽  
Stage 1 ◽  
Length Of Therapy

Purpose Intergroup Rhabdomyosarcoma Study Group (IRSG) studies III and IV showed improved failure-free survival (FFS) rates with vincristine, dactinomycin, and cyclophosphamide (VAC; total cumulative cyclophosphamide dose, 26.4 g/m2) compared with vincristine and dactinomycin (VA) for patients with subset-one low-risk embryonal rhabdomyosarcoma (ERMS; stage 1/2 group I/II ERMS or stage 1 group III orbit ERMS). The objective of Children's Oncology Group ARST0331 was to reduce the length of therapy without compromising FFS for this subset of low-risk patients by using VA in combination with lower-dose cyclophosphamide (total cumulative dose, 4.8 g/m2) plus radiotherapy (RT). Patients and Methods This noninferiority prospective clinical trial enrolled newly diagnosed patients with subset-one clinical features. Therapy included four cycles of VAC followed by four cycles of VA over 22 weeks. Patients with microscopic or gross residual disease at study entry received RT. Results With a median follow-up of 4.3 years, we observed 35 failures among 271 eligible patients versus 48.4 expected failures, calculated using a fixed outcome based on the FFS expected for similar patients treated on the IRSG D9602 protocol. The estimated 3-year FFS rate was 89% (95% CI, 85% to 92%), and the overall survival rate was 98% (95% CI, 95% to 99%). Patients with paratesticular tumors had the most favorable outcome. Three-year cumulative incidence rates for any local, regional, or distant failures were 7.6%, 1.5%, and 3.4%, respectively. Conclusion Shorter-duration therapy that included lower-dose cyclophosphamide and RT did not compromise FFS for patients with subset-one low-risk ERMS.

Vincristine (V), dactinomycin (A), and lower doses of cyclophosphamide (C) with or without radiation therapy for patients with newly diagnosed low-risk embryonal rhabdomyosarcoma (ERMS): A report from the Children’s Oncology Group (COG).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9509-9509 ◽  
Author(s):  
David Walterhouse ◽  
Alberto S. Pappo ◽  
Jane L Meza ◽  
John C. Breneman ◽  
Andrea Anita Hayes-Jordan ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Complete Response ◽  
Low Risk ◽  
Phase Iii ◽  
Newly Diagnosed ◽  
Group Iii ◽  
Group I ◽  
Phase Iii Study ◽  
Stage 1

9509 Background: Intergroup Rhabdomyosarcoma Study (IRS) trials showed improved survival with VAC compared with VA for patients with Stage 1 Group III (non-orbit) or Stage 3 Group I/II ERMS (see table). In COG ARST0331, we hypothesized that VA in combination with lower doses of C (total cumulative dose=4.8 g/m2) would produce the benefit of IRS-IV VAC with less toxicity for patients with Stage 1 Group III (non-orbit) or Stage 3 Group I/II low-risk ERMS. Methods: This single arm, non-inferiority, phase III study enrolled newly diagnosed patients with Stage 1 Group III (non-orbit) ERMS or Stage 3 Group I/II ERMS onto Subset 2. Therapy was 4 cycles of VAC followed by 12 cycles of VA over 46 weeks (total cumulative doses: V=54 mg/m2, A=21.6 mg/m2, C=4.8 g/m2). The radiation therapy dose was 36 Gy for Group IIA patients, 41.4 Gy for Group IIB/C patients, and 50.4 Gy for Group III patients. From 2004–2008 girls with Group III vaginal RMS did not receive radiotherapy if a complete response was achieved with chemotherapy with or without delayed resection. The primary endpoint was failure-free survival (FFS), and results were compared with a fixed expected outcome. Results: With a median follow-up of 3.0 yrs, we observed 16 failures vs. 7.8 expected failures. Estimated 3-yr FFS was 63% (95% CI: 46%, 75%) (n=60), and overall survival (OS) was 84% (95% CI: 68%, 93%). Estimated 3-yr FFS was 46% (95% CI: 23%, 67%) for girls with non-bladder genitourinary tract ERMS (n=21) and 75% (95% CI: 53%, 88%) for all other Subset 2 patients (n=39). Conclusions: We observed suboptimal FFS of patients with Subset 2 low-risk RMS using reduced total cyclophosphamide (4.8 g/m2). Results were complicated by the choice of no radiation therapy for girls with vaginal tumors. Future studies for low-risk RMS Subset 2 patients could investigate a dose of C between 4.8 and 26.4 g/m2 with VA and local radiotherapy. [Table: see text]

COMPONENTS OF MILK OF SIMMENTAL BREED BELONGING TO VARIOUS GENOTYPES

2020 ◽  
pp. 14-18
Author(s):  
Г.Н. ЛЕВИНА ◽  
А.И. НАЗАРЕНКО
Keyword(s):  
Milk Yield ◽  
Mass Fraction ◽  
Freezing Temperature ◽  
Energy Value ◽  
Group Iii ◽  
Holstein Breed ◽  
Group I ◽  
Milk Components ◽  
Beta Hydroxybutyrate ◽  
Stage 1

Изучены удой, калорийность и компоненты молока по трем лактациям у коров, имеющих разную кровность по породам: I группа — ¾ голштинской породы красно-пестрой масти (КГШ); ¼ симментальской породы (СИМ), II группа — ¾ СИМ; ¼ КГШ и III группа — ½ монбельярдской породы (МБ); ¼ СИМ; ¼ КГШ. Исследования проводили с 2014 по 2020 год на базе племенного завода ООО «Сапфир-Агро» Курской области. Удой коров был более 7000 кг молока за лактацию. Цель исследований заключалась в сравнительной оценке по удою и компонентам молока дочерей от маточного поголовья симментальской породы, имеющего кровность ½ по голштинской и быков монбельярдской, симментальской и голштинской пород для определения рационального приема дальнейшего совершенствования симментальской породы. В каждую группу отбирали животных по принципу пар-аналогов, с учетом возраста и даты отела, по 70 коров, полученных не менее чем от 3 быков-производителей. Животные находились в одинаковых условиях кормления и содержания. Установлено, что по суммарному удою за три лактации коровы разных генотипов равноценны (21,3—21,8 тыс. кг молока). Однако по калорийности молоко дочерей быков монбельярдской (72,7—74,7 ккал в 100 г) и симментальской (73,2—75,0 ккал) пород достоверно выше, чем в группе коров, имеющей кровность ¾ по КГШ породе (70,9—71,6 ккал), достоверное превосходство над коровами с ¾ КГШ было и по МДБ и казеину. МДЖ у всех животных была значительно выше 4,0% (4,12—5,01%). Достоверное превосходство коров II и III групп над сверстницами I группы наблюдалось на 1 и 3 стадиях, а по лактозе — на всех стадиях 1-й лактации. Температура замерзания молока была минимальной на 1 стадии всех лактаций. Максимальные величины бета-гидроксибутирата (БГБ) и ацетона в молоке были в 1 стадию всех лактаций. Изменчивость этих показателей была высокой у коров всех групп (57,0—217,0%). С учетом величины удоя и компонентов молока за три лактации снижение кровности по голштинам для потомства симментальской породы рационально, кроме того использование быков монбельярдской и симментальской породы на маточном голштинизированном поголовье симментальской породы способствует сохранению и развитию ее оригинальных качеств. Milk yield, energy value and milk components according to three lactations in cows with various pedigree by breeds were studied: Group I — ¾ of Holstein breed of red-and-white color (KGSh); ¼ of Simmental breed (SIM); Group II — ¾ SIM; ¼ KGSh; and group III — ½ of Montbéliarde breed (MB); ¼ SIM; ¼ KGSh. Research was carried out from 2014 until 2020 at OOO Sapfir-Agro stud farm located in the Kursk Region. Milk yield amounted to more than 7000 kg of milk per lactation. The purpose of study was to carry out comparative evaluation of pedigree stock calves belonging to Simmental breed with ½ pedigree of Holstein breed and bulls of Montbéliarde, Simmental, and Holstein breeds by milk yield and milk components to determine the rational method of further improvement of Simmental breed. Animals were chosen for each group according to the pair-analogue principle taking into account their age and date of calving. 70 cows from not less than 3 seed bulls were included. All of the animals were provided with the same feeding conditions and husbandry. It was determined that the cows with various genotypes are equivalent by total milk yield per three lactations (21.3—21.8 thousand kilograms of milk). However, energy value of milk obtained from the daughters of Montbéliarde (72.7—74.7 kcal per 100 g) and Simmental (73.2—75.0 kcal) bulls was reliably higher than that of the group of cows with ¾ pedigree of KGSh breed (70.9—71.6 kcal), and the reliable superiority over cows with ¾ KGSh was seen both in mass fraction of protein and casein. Mass fraction of fat was significantly higher than 4.0% (4.12—5.01%) in all animals. Reliable superiority of cows belonging to groups II and III over their counterparts belonging to group I was observed during stages 1 and 3, and superiority according to lactose was seen in all stages of the 1st lactation. Freezing temperature of milk was minimal on stage 1 of all lactations. Maximum values of beta-hydroxybutyrate (BHB) and acetone in milk were observed during stage 1 of all lactation. Variability of these parameters was high in cows belonging to all groups (57.0—217.0%). Taking milk yield and milk components values for three lactations into account, the decrease of pedigree by Holstein breed for Simmental offspring is rational. Also, the use of Montbéliarde and Simmental bulls on Holsteinised breeding stock of Simmental breed facilitates the preservation and development of its original qualities.

scholarly journals Results of the Intergroup Rhabdomyosarcoma Study Group D9602 Protocol, Using Vincristine and Dactinomycin With or Without Cyclophosphamide and Radiation Therapy, for Newly Diagnosed Patients With Low-Risk Embryonal Rhabdomyosarcoma: A Report From the Soft Tissue Sarcoma Committee of the Children's Oncology Group

2011 ◽  
Vol 29 (10) ◽  
pp. 1312-1318 ◽  
Author(s):  
R. Beverly Raney ◽  
David O. Walterhouse ◽  
Jane L. Meza ◽  
Richard J. Andrassy ◽  
John C. Breneman ◽  
...  
Keyword(s):  
Survival Rates ◽  
Embryonal Rhabdomyosarcoma ◽  
Study Group ◽  
Free Survival ◽  
Group Iii ◽  
Group I ◽  
Risk Patients ◽  
Group Ii ◽  
Stage 1

Purpose Patients with localized, grossly resected, or gross residual (orbital only) embryonal rhabdomyosarcoma (ERMS) had 5-year failure-free survival (FFS) rates of 83% and overall survival rates of 95% on Intergroup Rhabdomyosarcoma Study Group (IRSG) protocols III/IV. IRSG D9602 protocol (1997 to 2004) objectives were to decrease toxicity in similar patients by reducing radiotherapy (RT) doses and eliminating cyclophosphamide for the lowest-risk patients. Patients and Methods Subgroup A patients (lowest risk, with ERMS, stage 1 group I/IIA, stage 1 group III orbit, stage 2 group I) received vincristine plus dactinomycin (VA). Subgroup B patients (ERMS, stage 1 group IIB/C, stage I group III nonorbit, stage 2 group II, stage 3 group I/II) received VA plus cyclophosphamide. Patients in group II/III received RT. Compared with IRS-IV, doses were reduced from 41.4 to 36 Gy for stage 1 group IIA patients and from 50 or 59 to 45 Gy for group III orbit patients. Results Estimated 5-year FFS rates were 89% (95% CI, 84% to 92%) for subgroup A patients (n = 264) and 85% (95% CI, 74%, 91%) for subgroup B patients (n = 78); median follow-up: 5.1 years. Estimated 5-year FFS rates were 81% (95% CI, 68% to 90%) for patients with stage 1 group IIA tumors (n = 62) and 86% (95% CI, 76% to 92%) for patients with group III orbit tumors (n = 77). Conclusion Five-year FFS and OS rates were similar to those observed in comparable IRS-III patients, including patients receiving reduced RT doses, but were lower than in comparable IRS-IV patients receiving VA plus cyclophosphamide. Five-year FFS rates were similar among subgroups A and B patients.

Ovarian cancer: Autologous immunotherapy optimized by remote adjuvancy of a silicate-induced granuloma

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 12515-12515
Author(s):  
E. Garcia-Giralt ◽  
E. Lasalvia-Prisco ◽  
S. Cucchi ◽  
E. Lasalvia-Galante ◽  
J. Vazquez ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Tumor Growth ◽  
Performance Status ◽  
Advanced Ovarian Cancer ◽  
Ca 125 ◽  
Tumor Growth Inhibition ◽  
Primary Tumors ◽  
Group Iii ◽  
Group I ◽  
Group Ii

12515 Background: Advanced ovarian cancer has been included in several studies about an immunotherapy procedure using an Autologous Thermostable Hemoderivative Vaccine (ATHV) with anti-progressive tumor effect in metastatic malignant disease from different primary tumors (Cancer Biol Ther 2003). Like in most cancer vaccines, the net anti-tumoral effect of ATHV has low intensity despite the addition of several adjuvant steps: immune response enhancement by GM-CSF, immune tolerance break by cyclophosphamide or interference with CD4+CD25+ regulatory cells (E. Lasalvia-Prisco et al. ASCO 2003–2005). The inclusion of another adjuvant immunomodulatory step to ATHV in patients with advanced ovarian cancer was explored in this study. The tested adjuvancy was the local and remote immune-stimulation elicited by a subcutaneous silicate-granuloma (SSG), a phenomenon well proven in preclinical models (RM Fauve et al. Immune Lett 1987; E Fontan et al Proc Nat Acad of Sci 1983). Methods: Twenty four metastasic ovarian cancer patients, chemotherapy resistant, performance status ≤ 2 and CA-125 progressing serum level, were included in this institutional-IRB approved phase I/II trial. The patients were 3-group randomized, submitted to 3 different treatments: I only sympthomatic; II the previously reported ATHV and III ATHV + SSG. Tumor Growth was assessed in each case by the tumor size increase (RECIST measured). Mean difference in the 3 groups was statistically assessed (Student’s test). Results: Tumor Growth was slower in Group II and III than in Group I (p<0.02, p<0.005). Tumor growth was slower in Group III than in Group II (p<0.02). No relevant toxicities were detected. Conclusions: The results support that in advanced ovarian cancer an additional subcutaneous silicate granuloma as adjuvant agent optimizes the tumor growth inhibition through immunotherapy with an autologous thermostable hemoderivative vaccine. The bypass of the immune-ignorance could be discussed as its mechanism of action. No significant financial relationships to disclose.

Prostate cancer: Autologous immunotherapy optimized by indoleamine-2,3-dioxygenase (IDO)-inhibitor as immune-tolerance breaker

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 12509-12509
Author(s):  
E. M. Lasalvia-Prisco ◽  
E. Garcia-Giralt ◽  
S. Cucchi ◽  
J. Larrañaga ◽  
D. Wagner
Keyword(s):  
Prostate Cancer ◽  
Tumor Growth ◽  
Immune Tolerance ◽  
Performance Status ◽  
Tumor Growth Inhibition ◽  
Primary Tumors ◽  
Group Iii ◽  
Group I ◽  
Group Ii ◽  
Asco Meeting

12509 Background: In several peer review publications (Cancer Biol Ther 2003) our team has reported a procedure of cancer immunotherapy using an autologous thermostable hemoderivative vaccine (ATHV) with anti-progressive tumor effect in metastatic malignant disease from different primary tumors including prostate cancer. Last year (ASCO Meeting 2005) we have reported that the tolerance break for tumor associated antigens through the interference with CD4+CD25+ regulatory cells is a component of the mechanism of action of the ATHV antitumoral effect. Therefore, we have intended to optimize this autologous immunotherapy adding to the procedure different steps of immune-tolerance blockage selected due to their proven efficacy in pre-clinical models and their feasibility in the frame of ATHV technology. In this study we report the results in prostate cancer when the adjuvant step added was the translational knowledge the tolerance blockage by IDO-inhibition through 1-Methyl-Tryptophane or 1-MT (Munn DH et al J Exp Med 1999). Methods: Thirty metastasic prostate cancer patients, hormone and chemotherapy resistant, Performance Status ≤ 2 and PSA progressing serum level, were included in this institutional-IRB approved phase I/II trial. The patients were randomized in 3 groups submitted to 3 different treatments: I, only sympthomatic; II, the previously reported ATHV and III, ATHV + simultaneous s.c. 1-MT. Tumor size increase (tumor growth) measured according RECIST was registered in each case. Mean difference in the 3 groups was statistically assessed (Student’s t-test). Tryptophane to Kynurenine conversion was tested to assess IDO inhibition. Results: Tumor growth was significantly slower in Group II and III than in Group I (p<0.01 and p<0.005). Tumor growth was also significantly slower in Group III than in Group II (p<0.02). IDO-inhibition was confirmed only in Group III. No relevant toxicities were detected. Conclusions: These results support that additional tolerance break by IDO-inhibition optimizes the tumor growth inhibition through immunotherapy with an autologous thermostable hemoderivative vaccine. No significant financial relationships to disclose.

Benefit of Intensified Therapy for Patients With Local or Regional Embryonal Rhabdomyosarcoma: Results From the Intergroup Rhabdomyosarcoma Study IV

2000 ◽  
Vol 18 (12) ◽  
pp. 2427-2434 ◽  
Author(s):  
K. Scott Baker ◽  
James R. Anderson ◽  
Michael P. Link ◽  
Holcombe E. Grier ◽  
Stephen J. Qualman ◽  
...  
Keyword(s):  
Head And Neck ◽  
Residual Disease ◽  
Embryonal Rhabdomyosarcoma ◽  
Intermediate Risk ◽  
Primary Tumors ◽  
Free Survival ◽  
Group Iii ◽  
Group I ◽  
Resected Tumor ◽  
Risk Patients

PURPOSE: To compare failure-free survival (FFS) and survival for patients with local or regional embryonal rhabdomyosarcoma treated on the Intergroup Rhabdomyosarcoma Study (IRS)–IV with that of comparable patients treated on IRS-III. PATIENTS AND METHODS: Patients were retrospectively classified as low- or intermediate-risk. Low-risk patients were defined as those with primary tumors at favorable sites, completely resected or microscopic residual, or orbit/eyelid primaries with gross residual disease and tumors less than 5 cm at unfavorable sites but completely resected. Intermediate-risk patients were all other patients with local or regional tumors. RESULTS: Three-year FFS improved from 72% on IRS-III to 78% on IRS-IV for patients with intermediate-risk embryonal rhabdomyosarcoma (P = .02). Subset analysis revealed two groups that benefited most from IRS-IV therapy. FFS at 3 years for patients with resectable node-positive or unresectable (group III) embryonal rhabdomyosarcoma arising at certain favorable sites (head and neck [not orbit/eyelid or parameningeal] and genitourinary [not bladder or prostate]) improved from 72% on IRS-III to 92% on IRS-IV (P = .01). Similarly, 3-year FFS for patients with completely resected tumor or with only microscopic disease remaining (group I or II) at unfavorable sites improved from 71% on IRS-III to 86% on IRS-IV (P = .04). Only patients with unresectable embryonal rhabdomyosarcoma (group III) at unfavorable sites had no improvement in outcome on IRS-IV (3-year FFS for IRS-III and IRS-IV, 72% and 75%, respectively; P = .31). CONCLUSION: IRS-IV therapy benefited certain subgroups of patients with intermediate-risk embryonal rhabdomyosarcoma. A doubling of the intensity of cyclophosphamide (or ifosfamide equivalent) dosing per cycle between IRS-III and IRS-IV is thought to be a key contributing factor for this improvement.

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