Affiliation:
1. All India Institute of Medical Sciences(AIIMS)
2. All India Institute of Medical Sciences (AIIMS)
Abstract
Abstract
Purpose
This phase II trial is designed to test whether the performance status(PS) of metastatic non-small cell lung cancer(mNSCLC) patients(pts) can improve with chemotherapy if their poor PS(Eastern Cooperative Oncology Group(ECOG)PS of ≥ 2) is due to disease burden rather than comorbidities.
Methods
Age18-65 years, Charlson’s comorbidity index < 9, serum albumin ≥ 3.5g/dl, adequate bone marrow and organ function, & ECOG PS ≥ 2 as judged by the worst score of three independent physicians were administered 3 doses of weekly paclitaxel at 60mg/m2/dose. The primary endpoint was an improvement in ECOG PS by 1 point at 4 weeks; others: toxicity (CTCAE v 5.0), quality of life(QoL)assessment at baseline and 4 weeks by EORTC QLQ-C30 and EORTC QLQ-LC13. Optimal Simon’s 2-stage design was used.
Results
Forty-six patients were included with a median age of 56years(interquartile range, IQR 54–59), 12(26%) had comorbid conditions, and 87% with ECOG PS 3/4. PS improved in 11 pts at 4 weeks and in 7 beyond this time point. Grade 3/4 toxicities are seen in 20%(most common: anemia and diarrhea). At a median follow-up of 4.8m (95% CI: 3.27–14.9), the median progression-free survival & overall survival were 3.3 months (95% CI: 2.36–5.6) & 6.8months (95% CI 2.47–8.8),respectively. QoL improved for global QoL, role functioning, pain, dyspnea, insomnia, pain in chest, pain in other parts, & worsened for alopecia and sore mouth.
Conclusions
Abbreviated chemotherapy is a useful, well-tolerated strategy in carefully selected poor PS mNSCLC patients that can improve PS and QoL. Clinical trial information: CTRI/2020/01/022617.
Publisher
Research Square Platform LLC