Randomized phase III study comparing the first-line chemotherapy regimens in patients with driver mutation-negative advanced non-small cell lung cancer and poor performance status complicated with chronic obstructive pulmonary disease

Abstract

Background: Patients with non-small cell lung cancer (NSCLC) complicated with chronic obstructive pulmonary disease (COPD) with poor performance status (PS) are common in clinical practice with few related studies. Present studies have found that weekly low-dose docetaxel or gemcitabine combined with platinum is suitable for elderly or poor PS patients with advanced NSCLC.Methods: Untreated advanced driver mutation-negative NSCLC patients with COPD and PS ≥2 were enrolled in this double-blind randomized trial. Both groups controlled their COPD symptoms according to the GOLD guidelines. The anti-tumor regimens included docetaxel (37.5 mg/m 2 , D1, D8)/carboplatin (AUC 5.0) (DC group) and gemcitabine (1,000 mg/m 2 , D1, D8)/carboplatin (AUC 5.0) (GC group) were used every 3 weeks with continuous chemotherapy for 4-6 cycles or until disease progression. The primary endpoints were progression-free survival (PFS), and overall survival (OS).Results: Among the 52 patients (DC, n=25; GC, n=27), the median follow-up time was 12.3 months.There was no significant difference in tumor overall response rate (ORR; DC, 20.0% vs. GC, 22.2%, P=0.845) and disease control rate (DCR; DC, 72.0% vs. GC, 74.1%, P=0.064) between the 2 groups.The median PFS (GC, 6.5 vs. DC, 5.5 months; P=0.296) and the median OS (GC, 14.9 vs. DC, 12.3 months; P=0.548) of the GC group was slightly longer than the DC group. The main adverse reactions were myelosuppression and there were few adverse reactions of grade 3-4. Compared with the anti-tumor therapy only group in previous literature, the median PFS in this study was longer (6.2 months, 95% CI: 3.533-6.733 vs. 3.5 months, 95% CI: 2.432-4.568; P=0.589). There was also no significant difference in median OS and median PFS between the 2 groups (14.0 vs. 15.0 months, P=0.718).Chemotherapy cycle (P<0.001) was an independent prognostic factor for PFS, while chemotherapy cycle (P=0.011) and PS (P=0.041) were independent prognostic factors for OS. Conclusions: Weekly low-dose docetaxel or gemcitabine combined with carboplatin chemotherapy regimens can yield survival benefits and a tolerable safety profile in patients with driver mutation-negative 2574 Gao et al. Chemotherapy regimen in NSCLC patients complicated with COPD

Exploration of the Use of Natural Compounds in Combination with Chemotherapy Drugs for Tumor Treatment

“…Myelosuppression is one of the main adverse reactions of many chemotherapy drugs, including cyclophosphamide, paclitaxel, pemetrexed, and gemcitabine, which seriously affects the therapeutic effect of chemotherapy drugs [ 112 , 113 ]. Chemotherapy-induced bone marrow suppression can be manifested as neutropenia, leukopenia, and anemia [ 114 ].…”

Diagnosis of Metastatic Non-Small Cell Lung Cancer during Hospitalization: Missed Opportunity for Optimal Supportive Care?

“…Moreover, about half of new diagnoses are stage IV, with 1- and 5-year survival rates of approximately 31.3% and 5.8%, respectively. A paucity of data exists regarding patients with advanced NSCLC who are diagnosed while they are inpatients, a population that poses a particularly challenging clinical dilemma as the evolution in treatment options for NSCLC has led to possible benefits even in those with a poor performance status [ 14 , 15 , 16 , 17 ].…”

Plasma Soluble Podoplanin as a Biomarker of Hypercoagulability and Cellular Immunity Status in Patients With Non-small Cell Lung Cancer

“… 1 According to cell origin, lung cancer is classified into 2 main histologic groups: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), with the latter accounting for ∼85% of all lung cancers. 2 It is widely recognized that people with cancer are more likely to experience thrombotic events, 3 , 4 and individuals with lung cancer are at highest risk for these events. 5 Numerous studies have depicted that lung cancer as linked to hypercoagulability through activation of the coagulation and fibrinolytic systems.…”