Randomized trial of cisplatin versus cisplatin plus mitolactol versus cisplatin plus ifosfamide in advanced squamous carcinoma of the cervix: a Gynecologic Oncology Group study
| Autor: | George A. Omura, David G. Mutch, M L Berman, J A Blessing, D L Clarke-Pearson, L Vaccarello, B Anderson |
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| Rok vydání: | 1997 |
| Předmět: |
Adult
Cancer Research medicine.medical_specialty medicine.medical_treatment Urology Uterine Cervical Neoplasms chemistry.chemical_compound Age Distribution Mitolactol Antineoplastic Combined Chemotherapy Protocols medicine Carcinoma Humans Ifosfamide Prospective Studies Mesna Aged Cisplatin Aged 80 and over Chemotherapy business.industry Remission Induction Middle Aged medicine.disease Survival Analysis Nitrogen mustard Surgery Squamous carcinoma Oncology Epidermoid carcinoma chemistry Carcinoma Squamous Cell Female business medicine.drug |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 15(1) |
| ISSN: | 0732-183X |
| Popis: | PURPOSE Cisplatin, mitolactol (dibromodulcitol), and ifosfamide have been the most active single agents in squamous carcinoma of the cervix identified so far by the Gynecologic Oncology Group (GOG). Combinations of cisplatin plus ifosfamide and cisplatin plus mitolactol are prospectively compared with cisplatin alone. PATIENTS AND METHODS Patients were randomized to receive cisplatin 50 mg/m2 or the same dose of cisplatin plus mitolactol (C + M) 180 mg/m2 orally on days 2 to 6, or cisplatin plus ifosfamide (CIFX) 5 g/m2 given as a 24-hour infusion plus mesna 6 g/m2 during and for 12 hours after the ifosfamide infusion, every 3 weeks for up to six courses. Of 454 patients entered, 438 were eligible and analyzed for response and survival. RESULTS CIFX had a higher response rate (31.1% v 17.8%, p = .004) and longer progression-free survival (PFS) time (P = .003) compared with cisplatin alone. The median times to progression or death were 4.6 and 3.2 months, respectively. C + M showed no significant improvement in these parameters compared with cisplatin alone. Survival was associated with initial performance score (PS; 0 was more favorable; P < .001) and with age (younger was unfavorable, P = .025). There was no significant difference in overall survival between cisplatin and either of the combinations. Leukopenia, renal toxicity, peripheral neurotoxicity, and CNS toxicity were more frequent with CIFX (P < .05). CONCLUSION CIFX improved the response rate and PFS duration in advanced cervix cancer compared with cisplatin alone, but at the cost of greater toxicity and with no improvement in survival. |
| Databáze: | OpenAIRE |
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