EVALUATION OF THE ROLE OF GEMCITABINE AND ERLOTINIB IN STAGE IIIB AND STAGE IV NSCLC ADENOCARCINOMA OF LUNG AS A FIRST LINE CHEMOTHERAPY REGIMEN AND ASSESSING THE ACUTE TOXICITY, OVERALL SURVIVAL AND PROGRESSION FREE SURVIVAL RESPECTIVELY.

Abstract

INTRODUCTION: 2 nd rd According to Globocan 2020 lung cancer is 2 most common malignancy in males and 3 most common in the females. st Previous studies have showed EGFR-tyrosine-kinase inhibitors erlotinib and getinib efcacy as 1 line treatment for patients with activating EGFR mutations. Also, Gemcitabine is drug of choice in inoperable and locally advanced metastatic NSCLC. With the purpose study was undertaken to evaluate the role of gemcitabine and erlotinib in stage IIIB and stage IV NSCLC adenocarcinoma of lung MATERIAL AND METHOD: 2 35 Patients with stage IIIB and IV fullling criteria were given Inj. Gemcitabine 1 gm/m D1 and D8 IV & Tab erlotinib 150 mg PO daily repeated every 21 days, 6 cycles. Post 6 cycles of chemotherapy tab erlotinib 150 mg given till disease progression. Tumor response assessed by RECIST 1.1. Toxicity assessed by CTCAE version 5.0. RESULT: Adrenal metastasis was most common followed by lung, bone, malignant pleural effusion and liver metastasis. a median follows up in this study was 33 weeks. Toxicities noted were anemia, thrombocytopenia, febrile neutropenia, GI toxicities and rash. In post 3 cycles of chemotherapy, out of 35 patients,62.86 % were having partial response for primary and 34.29 % (n=12) for metastatic lesions. In post 6 cycles of chemotherapy there was a reduction in the partial response patients and a steep rise in stable disease patients. In Post 12 weeks of 6 cycles of chemotherapy more patients having a progressive disease, very little, 5.71 % having PR and 25.71 % were having a stable disease. DISCUSSION: The median PFS and median OS was 4.1 and 5.6 months respectively whereas Grade 3 toxicity was also seen in gemcitabine plus erlotinib arm. INTACT 1 trial-getinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: A phase III trial showed that getinib in combination with gemcitabine and cisplatin in chemotherapy-naive patients with advanced NSCLC did not have improved efcacy over gemcitabine and cisplatin alone. The median overall survival was 18.3 months and the median PFS was 7.6 months, in our study it come out to be 8.25 months and 4.5 months respectively. Also noted Grade 3 febrile neutropenia, anemia, thrombocytopenia, vomiting & diarrhea same as our study. CONCLUSION: Standard treatment for patients with an activating EGFR mutation is rst-line single-agent EGFR-tyrosine kinase inhibitor and combination chemotherapy such as gemcitabine plus erlotinib is improving survival