(ChemotherapyAdvisor) – Intensification of chemotherapy for nonmetastatic rhabdomyosarcoma (RMS) and other chemotherapy-sensitive soft tissue sarcoma (STS) provide no survival advantage, according to an international team of researchers. This conclusion is based on a study entitled “Randomized Comparison of Intensified Six-Drug Versus Standard Three-Drug Chemotherapy for High-Risk Nonmetastatic Rhabdomyosarcoma and Other Chemotherapy-Sensitive Childhood Soft Tissue Sarcomas: Long-Term Results from the International Society of Pediatric Oncology MMT95 Study,” which was published in the July 10 issue of the Journal of Clinical Oncology.
In this study (known as MMT95), the investigators aimed to explore the survival advantage for an intensified chemotherapy strategy in a randomized trial. To meet this aim, 457 previously untreated patients diagnosed with one of the following cancer types participated in the study: incompletely resected embryonal RMS; undifferentiated sarcoma; soft tissue primitive neuroectodermal tumor at all sites except paratesticular, vagina, and uterus; or alveolar RMS. Patients were randomly assigned to receive either ifosfamide, vincristine, and dactinomycin (IVA) or a six-drug combination (IVA plus carboplatin, epirubicin, and etoposide) over a 27-week period.
The investigators reported the following results. Overall survival (OS) for all patients was 81% (95% CI, 77% – 84%) at 3 years. No significant difference in outcome in either OS or event-free survival was noted between the 2 arms (3-year OS: 82% [95% CI, 76% – 86%] for IVA and 80% [95% CI, 74% – 85%] for the 6-drug arm). Toxicity was significantly greater (infection, myelosuppression, and mucositis) in the 6-drug arm.
The investigators concluded: “Intensification of chemotherapy for nonmetastatic RMS and other chemotherapy-sensitive STS provides no survival advantage or reduction in the intensity of local therapy and adds toxicity.”