ABSTRACT
PURPOSE: This study was undertaken to determine the effect of adjuvant chemotherapy combined with reduced-dose craniospinal irradiation (CSI) on survival and neurocognitive sequelae of radiotherapy (RT) in patients with average- risk medulloblastoma above the age of 3 years. METHODS: Thirty-three children between 3 and 10 years of age with average-risk medulloblastoma were treated with postoperative reduced-dose CSI (24.0 Gy) and 30.6 Gy of local RT (total of 54.6 Gy) and then with adjuvant chemotherapy consisting of cisplatin, vincristine, and cyclophosphamide every 4 weeks for 8 cycles. RESULTS: At 5 years, event-free survival (EFS) was 79%, while overall survival (OS) was 85%. Sites of relapse were local in 3%, neuraxis in 9% and both local and neuraxis in 9% of the patients. Chemotherapy was well tolerated. Hematopoietic toxicity was the most predominant side effect followed by vomiting and ototoxicity. No grade III or IV nephrotoxicity or neurotoxicity and no treatment-related deaths were encountered. Insignificant decline of intelligence quotient (IQ) was reported in 28.6% of the patients. CONCLUSION: The preliminary results of adjuvant chemotherapy after reduced-dose CSI in average-risk medulloblastoma patients are encouraging and effective, and can be applied safely with acceptable toxicity.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Cerebellar Neoplasms/therapy , Chemoradiotherapy, Adjuvant , Cranial Irradiation , Medulloblastoma/therapy , Radiation Dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Cerebellar Neoplasms/mortality , Cerebellar Neoplasms/pathology , Chemoradiotherapy, Adjuvant/adverse effects , Child , Child, Preschool , Cisplatin/administration & dosage , Cognition/drug effects , Cognition/radiation effects , Cranial Irradiation/adverse effects , Cyclophosphamide/administration & dosage , Disease-Free Survival , Female , Follow-Up Studies , Humans , Kaplan-Meier Estimate , Male , Medulloblastoma/mortality , Medulloblastoma/secondary , Neoplasm Recurrence, Local , Prospective Studies , Time Factors , Treatment Outcome , Vincristine/administration & dosageABSTRACT
AIM: The aim of this Phase II study was to evaluate the activity and safety of biweekly pegylated liposomal doxorubicin (PLD) and oxaliplatin (L-OHP) in patients with platinum-taxane resistant ovarian cancer. MATERIALS AND METHODS: Treatment consisted of PLD (20 mg/m²) on Day 1; and L-OHP (50 mg/m²) administered on Days 1 and 2, every two weeks. Response to therapy was assessed using the Response Evaluation Criteria in Solid Tumors RECIST ; toxicity was evaluated by the National Cancer Institute Common Toxicity Criteria. RESULTS: Forty patients pretreated with platinum/taxane chemotherapy, with a median age of 61 years, were recruited for the study. Thirty-eight patients were available for response evaluation: three complete responses and nine partial responses were registered; resulting in an overall response rate of 31.5%. Twenty-eight patients gained clinical benefit (73.7%) from this chemotherapy regimen. Median time to progression (TTP) and overall survival (OS) were 5.5 and 10 months respectively. The hematological and non-hematological toxicity profile was favorable. No Grade 4 toxicity was observed. Major toxicities included Grade 3 neutropenia (13.2%), Grade 2 palmar-plantar erythrodysesthesia (7.9%), and Grade 1-2 neuropathy in 15.8% of patients. CONCLUSION: Biweekly PLD and L-OHP combination has high activity, with less than anticipated adverse toxicity, for treatment of platinum-resistant ovarian cancer. A comparison of the doublet PLD/L-OHP with single-agent treatment is warranted.
