Phase II study of nab‐paclitaxel + carboplatin for patients with non‐small‐cell lung cancer and interstitial lung disease

• Autor: Kenmotsu, Hirotsugu ; Yoh, Kiyotaka ; Mori, Keita ; Ono, Akira ; Baba, Tomohisa ; Fujiwara, Yutaka ; Yamaguchi, Ou ; Ko, Ryo ; Okamoto, Hiroaki ; Yamamoto, Nobuyuki ; Ninomiya, Takashi ; Ogura, Takashi ; Kato, Terufumi
• Assuntos: Aged ; Aged, 80 and over ; Albumins - administration & dosage ; Albumins - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Carboplatin ; Carboplatin - administration & dosage ; Carboplatin - adverse effects ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - mortality ; Chemotherapy ; Cytotoxicity ; Epidermal growth factor ; exacerbation ; Female ; Histology ; Hospitals ; Humans ; Infections ; interstitial lung disease ; Leukopenia ; Lung cancer ; Lung diseases ; Lung Diseases, Interstitial - complications ; Lung Diseases, Interstitial - epidemiology ; Lung Neoplasms - drug therapy ; Lung Neoplasms - mortality ; Male ; Medical prognosis ; Middle Aged ; nab‐paclitaxel ; Neutropenia ; Non-small cell lung carcinoma ; non‐small‐cell lung cancer ; Original ; Paclitaxel ; Paclitaxel - administration & dosage ; Paclitaxel - adverse effects ; Patients ; Pharmaceuticals ; Pneumonia ; Prospective Studies ; Pulmonary fibrosis ; Registration ; Response rates ; Thrombocytopenia ; Toxicity
• É parte de: Cancer science, 2019-12, Vol.110 (12), p.3738-3745
• Descrição: The prognosis of non‐small‐cell lung cancer (NSCLC) patients with interstitial lung disease (ILD) is poor, and 5%‐20% of those receiving chemotherapy experience ILD exacerbation. To evaluate the safety and efficacy of nab‐paclitaxel plus carboplatin for NSCLC patients with ILD, we undertook a multicenter phase II study. Chemotherapy‐naïve patients with advanced NSCLC and mild or moderate ILD received nab‐paclitaxel (100 mg/m2, days 1, 8, and 15) plus carboplatin (area under the curve = 6, day 1) every 3 weeks for 4 cycles (maximum, 6 cycles). Interstitial lung diseases were diagnosed based on criteria for fibrosing interstitial pneumonia. The primary endpoint was the prevalence of exacerbation‐free ILD 28 days after completion of protocol treatment. Secondary endpoints were response rate, progression‐free survival, overall survival, prevalence of exacerbation‐free ILD, and toxicity. Ninety‐four patients were enrolled, and 92 patients received any protocol treatment. Median age was 70 years, and 58% had nonsquamous histology. In the primary analysis, the prevalence of exacerbation‐free ILD 28 days after protocol treatment was 95.7% (88/92; 90% confidence interval, 90.3‐98.5), which met the primary endpoint. Response rate was 51% (95% confidence interval, 40%‐62%). At the time of data cut‐off, median progression‐free survival was 6.2 months, and median overall survival was 15.4 months. The most common grade 3/4 adverse events were neutropenia (75%), leukopenia (53%), anemia (48%), and thrombocytopenia (20%). Two treatment‐related deaths (1 each of pulmonary infection and ILD exacerbation) were observed. This study showed that a combination of nab‐paclitaxel with carboplatin was tolerable in NSCLC patients with mild or moderate ILD in terms of safety. This study is registered at the University Hospital Medical Information Network (UMIN) Clinical Trial Registry (UMIN 000012989). This phase II study was to evaluate the safety for non‐small‐cell lung cancer (NSCLC) patients with interstitial lung disease (ILD). The prevalence of exacerbation‐free ILD 28 days after protocol treatment was 95.7%. Median progression‐free survival was 6.2 months, and median overall survival was 15.4 months for NSCLC patients with ILD. Nab‐paclitaxel plus carboplatin was tolerable in NSCLC patients with ILD.
  
• Editor: England: John Wiley & Sons, Inc
  
• Idioma: Inglês