PURPOSE: The purpose of this trial was to evaluate the activity and feasibility of CBDCA together with NVBO as first line treatment in patients with advanced NSCLC.
METHODS: Patients with advanced NSCLC received NVBO 80 mg/m2 on D1 and D8 with CBDCA AUC5 on D1 every three weeks. In stage III, chemotherapy was followed by external radiotherapy. The outcomes include following: response, median overall survival (mOS) and median progression free survival (mPFS). The difference in response relative to baseline characteristics was determined using Pearson Chi-square test. Differences in OS and PFS relative to baseline characteristics were evaluated for significance using Log-rank test.
RESULTS: 259 patients were treated: 209 men (80,7%) and 50 women (19,3%), median age 65 years. ECOG performance status at inclusion was PS 0 in 47 (18,2% patients, PS 1 in 185 (71,7%) and PS 2 in 26 (10,1%) patients. Most patients had stage IIIB 97 (37,5%) and stage IV NSCLC 130 (50,2%), only 32 (12,4%) were stage IIIA . Adenocarcinoma was confirmed in 52 patients (20,1%), squamous-cell carcinoma in 152 (58,7%), large-cell carcinoma in 8 (3,1%) and other in 47 (18,4%). Complete response was confirmed in 1 (0,4%) patient, partial response in 121 (46,7%), stable disease in 58 (22,4%), 79 (30,5%) patients progressed. The regimen was well tolerated. Median cycles was 4, the dosage of NVBO was without changes in 159 (61%) patients, the dosage of NVBO was reduced in 12 (4,7%) and escalated in 64 (24,8%). In 23 (8,9%) of patients was the dosage of NVBO reduced after escalation. Major toxicities (Grade 3-4) were neutropenia in 69 (26,9%), leucopenia in 51 (19,8%), anemia in 7 (2,7%), and thrombocytopenia in 6 (2,3%) patients. Febrile neutropenia was observed in 17 (6,6%) patients. Gastrointestinal toxicity grade 3-4 was observed in 47 (18,4%) patients. The estimated mOS was 13,8 moths. and the estimated mPFS was 9,4 months by median follow-up 8,5 months. The differences between groups of pts according to PS (0+1 vs. 2) were statistically significant (p < 0,001) better for patiens with PS 0+1.
CONCLUSIONS: In this group of 259 non-selected patients with advanced NSCLC was the treatment with full NVBO and CBDCA in first line more convenient and well tolerated with evidence of high antitumour activity. This combination was active in all groups patients according histology.
CLINICAL IMPLICATIONS: Therapeutic regimen with full NVBO and CBDCA is in patients with advanced NSCLC effective with a simple administration and with favorable toxicity profile.
DISCLOSURE: The following authors have nothing to disclose: Jana Skrickova, Marcela Tomiskova, Lenka Babickova, Tereza Janaskova, Vitezslav Kolek, Jaromir Roubec, Ivona Grygarkova
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