Phase II study of carboplatin + weekly paclitaxel for advanced lung squamous cell carcinoma with idiopathic interstitial pneumonia (Hanshin Cancer Group IP001).

Advanced lung cancer complicated by idiopathic interstitial pneumonia (IIP) is difficult to treat because anticancer agents can worsen IIP. The efficacy and risks of treatment remain unknown and no standard chemotherapy regimen has been established for this condition. The central institutional review board approved this study. Radiologists and pulmonologists independently determined the sub-type of IIP. Eligibility criteria included age > 20 years, PS 0-1, adequate organ function, and written informed consent. Chemotherapy consisted of Carboplatin (CBDCA; area under the curve = 5), day 1 and Paclitaxel (PAC) 70 mg/m, days 1, 8, and 15. Participants received chemotherapy every 4 weeks, for 4-6 cycles. Between January 2013 and October 2018, 36 patients enrolled in the study and 35 patients underwent chemotherapy. Patient characteristics were as follows: median age 73 years (range: 66-80 years), male/female (31/4), stage IIIA/IIIB/IV/post-op recurrence = 7/8/16/4, smoking yes/no = 34/1. Subtypes of IIP included idiopathic pulmonary fibrosis in 11(31.4%), combined pulmonary fibrosis and emphysema in 7, unclassified in 16, and interstitial linear abnormality in one. The response rate was 45.7% [0.288-0.634] with Complete Response/Partial Response/Stable Disease/Progressive Disease = 0/16/15/3, progression-free survival of 5.75 [4.70-6.67] months, and median overall survival of 9.99 [7.92-17.45] months. The acute exacerbation rate of IIP was 8.6% (3/35). CBDCA + weekly PAC had an acceptable acute exacerbation rate with a reasonable response rate, suggesting that it is a promising therapy for advanced squamous cell lung cancer with IIP. The risk factors of acute exacerbation remain to be investigated.