Pembrolizumab plus pemetrexed-carboplatin combination in first-line treatment of advanced non-squamous non-small cell lung cancer: a multicenter real-life study (CAP29)

Abstract

Background: Pembrolizumab combined with chemotherapy is now first-line standard of care in advanced non-small cell lung cancer. This real-life study aimed to assess efficacy and safety of carboplatin-pemetrexed plus pembrolizumab in advanced non-squamous non-small cell lung cancer.Methods: CAP29 is a retrospective, observational, multicenter real-life study conducted in 6 French centers. We evaluated efficacy of first-line setting chemotherapy plus pembrolizumab (November 2019 to September 2020) in advanced (stage III-IV) non-squamous non-small cell lung cancer patients without targetable alterations. Primary endpoint was progression-free survival. Secondary endpoints were overall survival, objective response rate and safety.Results: With a median follow-up of 4.5 months (0 to 22 months), a total of 121 patients were included. Baseline characteristics were: median age of 59.8 years with 7.4% ≥75 years, 58.7% of males, 91.8% PS 0-1, 87.6% of stage IV with ≥3 metastatic sites in 62% of cases. Patients had brain and liver metastases in 24% and 15.7% of cases, respectively. PD-L1 was <1% (44.6%), 1-49% (28.1%) and ≥50% (21.5%). Median progression-free survival and overall survival achieved 9 and 20.6 months, respectively. Objective response rate was 63.7% with 7 prolonged complete responses. Survival benefit seemed to be correlated with PD-L1 expression. Brain and liver metastases were not statistically associated with decreased overall survival. Most common adverse events were asthenia (76%), anemia (61.2%), nausea (53.7%), decreased appetite (37.2%) and liver cytolysis (34.7%). Renal and hepatic disorders were the main causes of pemetrexed discontinuation.Grade 3-4 adverse events concerned 17.5% of patients. Two treatment-related deaths were reported.Conclusions: First-line pembrolizumab plus chemotherapy confirmed real-life efficacy for patients with advanced non-squamous non-small cell lung cancer. With median progression-free survival and overall survival of 9.0 and 20.6 months, respectively and no new safety signal, our real-life data are very close to results provided by clinical trials, confirming the benefit and the manageable toxicity profile of this combination.

Pembrolizumab-combination therapy for NSCLC- effectiveness and predictive factors in real-world practice

“…The median OS was 16.2 months (95% CI: 10.3-20.6) for PD-L1 ≥ 1% and 17.2 months (95% CI: 10.8-20.6) for PD-L1 < 1%. The percentage of patients who remained in followup after one year of treatment was similar in both subgroups (approximately 55%) (21).…”

“…A retrospective analysis from six French CAP29 centres evaluated a group of 121 patients receiving immunochemotherapy, regardless of PD-L1 expression, 44.6% had low PD-L1 expression and 21% PD-L1>50% expression in TC ( 22 ). The median OS was 15.1 months (95% CI: 13.0 - NR) in the PD-L1 <1% group, 18.0 months (95% CI: 17.0 - NR) in the PD-L1 1-49% group and was not reached in the PD-L1 >50% group.…”

“…No analysis by histological type was presented. The differences between subgroups were significant with respect to PFS (p=0.0016) ( 22 ).…”

“…Another study by Liu et al analysed a group of 364 patients in good performance status (ECOG 0-1) diagnosed with squamous-cell lung cancer (21). Of these, 94 patients had expression of PD-L1 <1% (26%).…”