Phase IIb trial comparing two concurrent cisplatin schedules in locally advanced head and neck cancer
| Autor: | Kainickal Cessal Thomachan, R. Rejnish Kumar, Kunnambath Ramadas, Preethi Sara George, Lekha Nair, Malu Rafi, K M Jagathnath Krishna |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Larynx Oncology Cancer Research medicine.medical_specialty cisplatin lcsh:RC254-282 03 medical and health sciences 0302 clinical medicine Internal medicine medicine Clinical endpoint Stage (cooking) Cisplatin business.industry Head and neck cancer lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens medicine.disease Acute toxicity Clinical trial Regimen 030104 developmental biology medicine.anatomical_structure Chemoradiation ORIGINAL ARTICLE: Head and Neck Cancer 030220 oncology & carcinogenesis head and neck cancer business medicine.drug |
| Zdroj: | South Asian Journal of Cancer, Vol 6, Iss 2, Pp 64-68 (2017) South Asian Journal of Cancer |
| ISSN: | 2278-4306 2278-330X |
| DOI: | 10.4103/2278-330x.208840 |
| Popis: | Background: Concurrent chemoradiation with 3 weekly cisplatin (100 mg/m2) is the standard of care for locally advanced head and neck cancer. However, this regimen has been shown to be associated with lesser compliance and higher toxicities. Hence, there is a need to explore alternative concurrent cisplatin regimens. Objectives: The objective of this study was to compare the efficacy and toxicities of 3 weekly cisplatin (100 mg/m2) with weekly cisplatin (40 mg/m2) concurrently with radiation in patients with locally advanced head and neck cancer. Patients and Methods: This phase IIb trial randomized 56 patients with Stage III and IV squamous cell carcinoma of oropharynx, hypopharynx, and larynx to Arm A or Arm B. Arm A received cisplatin 100 mg/m2 3 weekly and Arm B received cisplatin 40 mg/m2 weekly concurrently with radiation. The primary end point was disease-free survival (DFS) and secondary end points were overall survival (OS) and acute toxicity. DFS and OS were estimated using Kaplan–Meier method, and log-rank test was used to assess the difference in these distributions with respect to treatment. Results: The 2-year DFS in Arm A and Arm B was 64.5% and 52.8%, respectively (P = 0.67). The OS at 2 years was 71% and 61.1% in Arm A and Arm B, respectively (P = 0.61). There were no significant differences in acute hematological, renal, or mucosal toxicities between the two arms. Conclusion: This study showed a nonsignificant improvement in DFS and OS in the 3 weekly cisplatin arm over the weekly arm with comparable toxicities. The trial is registered with Clinical Trial Registry of India (CTRI registration number: CTRI/2013/05/003703, URL-http://ctri.nic.in). |
| Databáze: | OpenAIRE |
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