Randomized phase II trial of carboplatin + nab-paclitaxel versus cisplatin + gemcitabine for chemotherapy-naïve squamous cell carcinoma: North Japan lung cancer study group 1302
| Autor: | Yosuke Kawashima, Tomoya Kuda, Kana Watanabe, Kazuhiro Usui, Kei Takamura, Shunichi Sugawara, Taku Nakagawa, Yuka Fujita, Akimasa Sekine, Akira Inoue, Kenya Kanazawa, Toshiyuki Harada, Naoto Morikawa |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty medicine.medical_treatment Phases of clinical research Neutropenia Gastroenterology 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine medicine Lung cancer Cisplatin Chemotherapy business.industry Hematology General Medicine medicine.disease Gemcitabine Carboplatin Regimen 030104 developmental biology Oncology chemistry 030220 oncology & carcinogenesis Surgery business medicine.drug |
| Zdroj: | International Journal of Clinical Oncology. 26:515-522 |
| ISSN: | 1437-7772 1341-9625 |
| Popis: | A subset analysis of the CA031 trial showed significant improvement in the overall response rate after administration of carboplatin plus weekly albumin-bound paclitaxel compared to carboplatin plus paclitaxel for squamous cell carcinoma of the lung (SQ). We conducted this phase II study to compare carboplatin plus weekly albumin-bound paclitaxel (CnP) to cisplatin plus gemcitabine (CG), a standard regimen for SQ. Chemotherapy-naive patients with SQ were randomly assigned to receive cisplatin (80 mg/m2) on day 1 plus gemcitabine (1000 mg/m2) on days 1 and 8 every 3 weeks or carboplatin (area under the curve: 6 mg/mL/min) on day 1 plus nab-paclitaxel (75 mg/m2) on days 1, 8, and 15 every 3 weeks. The primary endpoint was overall response rate. The secondary endpoints were progression-free survival, overall survival, disease control rate, and toxicity. Between June 2013 and October 2018, 71 patients were enrolled and assigned to either the CG arm (n = 35) or the CnP arm (n = 36) of the study. The overall response rate was 43% [95% confidence interval (CI) 27.3–58.5] in the CG arm and 47% (95% CI 31.7–62.7) in the CnP arm. Although drug combination efficacies did not differ, there were differences in toxicity: hematologic toxicities (leukopenia, neutropenia, and thrombocytopenia) were found mostly in the CG arm, whereas anemia and sensory neuropathy were more common in the CnP arm. CnP had similar response as CG despite being a carboplatin-based regimen and toxicities differed between arms. Regarding ORR, CnP was comparable to CG for SQ. |
| Databáze: | OpenAIRE |
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