Improving the performance status in Advanced non-small cell lung cancer patients with Chemotherapy (ImPACt trial): a phase 2 study

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/m 2 /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.