The real-world experience with nivolumab in previously treated patients with advanced non-small cell lung cancer from a cancer center in India

Abstract

Background: PDL-1 inhibitors have emerged as the new standard of care for second line treatment of NSCLC. Methods: Eligible patients included, histologically proven NSCLC, ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1 or 2, age 18 years and above, availability of pre-treatment tumor specimen, adequate end organ function, at least one prior platinum-based therapy. Patients who received a minimum of 6 doses of nivolumab were eligible. Results: Eleven previously treated patients with chemotherapy, started on nivolumab from April of 2016 to December of 2018, were retrospectively studied and analysed. The median age of patients was 58 years. Eight (72.73%) of the eleven patients were male. Seven (63.64%) of the patients were current or former smokers. Majority of patients had non-squamous histology; seven (63.64%) adenocarcinoma and four (36.36%) squamous cell carcinoma. 5 (45.46%) of the patients received one prior therapy, three (27.27%) received two prior therapies, and three (27.27%) received three prior therapies. Four (36.36%) of the patients had brain metastasis. Two (18.18%) of the patients were more than 70 years of age. Median number of cycles of nivolumab administered were 10 (range, 6 to 21). At the time of analysis, the median PFS was 8 months (95% CI, 1.52-14.47) and median OS was 15 months (95% CI, 6.9-23.09). Treatment was well tolerated and generally side effects were grade 1 and grade 2, except two patients who develop grade 3/4 pneumonitis. Conclusions: This is a real-world study of eleven previously treated patients with chemotherapy, started on Nivolumab from April of 2016 to December of 2018. Although, our sample size was small, our data supports the use of nivolumab as a new treatment option for patients of stage 4 NSCLC.

Real world data in the era of Immune Checkpoint Inhibitors (ICIs): Increasing evidence and future applications in lung cancer

“…The vast majority of the real-world data about immunotherapy in lung cancer describes the activity, in terms of objective response rate (ORR), efficacy (in terms of overall survival, OS, and progression free survival, PFS) and the safety profile of the most common ICIs used in clinical practice (Table 1). Studies on pretreated NSCLC patients were all retrospective and showed outcomes comparable with those reported in the pivotal RCTs, with median PFS and median OS ranging from 1.8 to 4.9 months and from 7.9 to 14.6 months, respectively [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24]. Only one study showed a remarkable outcome for patients treated with nivolumab, with a median PFS exceeding 8 months and a median OS of over 15 months; however, this may be due to the small population (n = 11) considered for analysis [23].…”

“…Studies on pretreated NSCLC patients were all retrospective and showed outcomes comparable with those reported in the pivotal RCTs, with median PFS and median OS ranging from 1.8 to 4.9 months and from 7.9 to 14.6 months, respectively [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24]. Only one study showed a remarkable outcome for patients treated with nivolumab, with a median PFS exceeding 8 months and a median OS of over 15 months; however, this may be due to the small population (n = 11) considered for analysis [23]. There were no particular differences between real world experiences from Asian or non-Asian countries.…”

Clinical Trial and Real-World Outcomes of Patients With Metastatic NSCLC in the Post-Platinum–Based Chemotherapy Failure Setting

“… 21 Nevertheless, three additional real-world studies of nivolumab were excluded from this review due to the sample size restriction. 32 , 33 , 34 …”

Interaction between NSCLC Cells, CD8+ T-Cells and Immune Checkpoint Inhibitors Potentiates Coagulation and Promotes Metabolic Remodeling—New Cues on CAT-VTE

“…Advanced NSCLC has a very poor outcome, with a mean expected survival of about 7 months [25]. Immune checkpoint inhibitor (ICI) therapy for NSCLC seems to increase the patients' survival to a range between 8 and 15 months [26][27][28]. Nonetheless, the increase in the immune response induced by ICIs can cause secondary effects related to an unbalanced homeostasis of the systemic immune system [29].…”