Comparing a standard 3-weekly Paclitaxel and Carboplatin to weekly Paclitaxel and Carboplatin (same as in the 3-weekly arm) in Stage IV Metastatic NSCLC

Dr Prem Kumar Devdoss; Dr.Naveen Ravel

Volume : VIII, Issue : II, February - 2019

Comparing a standard 3-weekly Paclitaxel and Carboplatin to weekly Paclitaxel and Carboplatin (same as in the 3-weekly arm) in Stage IV Metastatic NSCLC

Dr Prem Kumar Devdoss, Dr. Naveen Ravel

Abstract :

Aim: Purpose of this study is to compare the efficacy of standard 3-weekly Paclitaxel and Carboplatin to weekly Paclitaxel and Carboplatin (same as in the 3-weekly arm) in Stage IV Metastatic NSCLC� Materials and methods: It is a two arm Prospective Randomized Controlled Trial. Twenty patients were randomized each to the control as well as the study (experimental) arm, fulfilling all the Inclusion criteriae. Eligible patients were either assigned to: • Arm1- Paclitaxel 75mg/m2 weekly on Days 1, 8 and 15, with Carboplatin area under the curve (AUC) = 5, on day 1 of each 28 days cycle; or • Arm 2 - Paclitaxel (175 mg/m2) and Carboplatin (AUC= 5), both on day 1 of each 21 days cycle. Treatment was planned for upto a maximum of four cycles. Patients who had symptomatic Brain and Bone metastases completed palliative Whole Brain / Bone Radiation, before being started on palliative chemotherapy, as per protocol. Results: In our study, an Overall Response rate of 20% (4/20 patients) in the experimental arm and 15% (3/20 patients) in the standard arm was observed, reflecting a trend, modestly in favour of the experimental weekly arm. An improved QOL was apparent in the weekly arm. The overall incidence of patients with a moderate to good QOL, was an overwhelming 75%, with 50% of these patients experiencing a very good QOL. Paradoxically, 20% of patients suffered a poor QOL, as well. The overall incidence of Gr 2/3 Neutropenia was observed to be 23%, with the weekly arm showing a significant reduction. The overall incidence of Gr 3/4 Anemia was noted to be 30% and 20% respectively, in our weekly and standard arms. The overall incidence of Gr 2/3 Peripheral sensory neuropathy in our weekly arm was noted to be 25%. The overall incidence of Gr 2/3 Peripheral sensory neuropathy in our standard arm was noted to be an overwhelming 45%. The overall incidence of Myalgia / Arthralgia in the weekly arm was observed to be 25%, and that of Myalgia / Arthralgia in the standard arm was observed to be as high as 50%. Conclusion: Treating Advanced Stage-IV NSCLC patients with combination chemotherapy using a weekly Paclitaxel regimen along with standard dose Carboplatin, is not only feasible, but also better than the conventional Paclitaxel and Carboplatin given every 21 days. Patients are also able to complete the planned number of Chemotherapy cycles, with a performance status reasonably well maintained and eligible for further maintenance therapy. And especially, the favourable Non-hematologic toxicity profile of this weekly combination, makes it the ideal treatment option for patients with advanced NSCLC, even in the elderly and in patients with a reduced performance status.