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.
MethodsAge18-65 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.
ResultsForty-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.
ConclusionsAbbreviated 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.
Patient eligibilityAll patients of histologically proven stage IIIC/IV NSCLC (AJCC 8th ed)(Rami-Porta et al. 2014), aged 18-65 years, with ECOG PS of 2 or more, were eligible for this study. Inclusion criteria also encompassed adequate bone marrow, liver, and kidney function: de ned as hemoglobin of ≥ 8g/dl, platelet count of ≥ 1,00,000/mm 3 , ANC of ≥ 1500cells/ mm 3 , bilirubin less than 2 times ULN, transaminases less than 3 times ULN, and an estimated GFR of ≥ 30ml/min/BSA, respectively. Charlson's comorbidity index(CCI) score (Charlson et al. 1987;Zhao et al. 2017) was calculated at baseline. Participants should have had a CCI score of less than 9 with any comorbid conditions under control and a serum albumin of ≥ 3.5g/dl.Patients who were pregnant or lactating, had secondary malignancy, had HIV or hepatitis B or C positive status, known driver mutation-positive status for EGFR/ALK/ROS1, and symptomatic untreated brain metastasis was excluded from the study. Unknown/pending driver mutation status patients were allowed to be enrolled, and if they were found to have these alterations during the course, they were excluded from the study. Treated brain metastasis or those with asymptomatic brain metastasis were allowed. Informed consent was obtained from all participants.
Treatment/InterventionEnrolled patients received paclitaxel at 60mg/m 2 of body surface area (BSA) intravenously (IV) over 1 hour every seven days (±1 da...