Nivolumab in Clinical Practice: Real World Experience in an Argentina Oncologic Center: Track: Immunotherapy.

RIZZO M.; MANDO P. ; DE LA PUENTE, CONSTANZA PÉREZ; PUPARELLI, CARMEN; LOSCO, FEDERICO; CHACÓN, MATÍAS; CHACÓN, REYNALDO; MARTÍN, CLAUDIO

Congreso; Latin American congress of lung cancer; 2016

IASLC

Immunotherapy has demonstrated promising results in cancer patients. Immune checkpoint inhibition with the anti- PD-1 antibody nivolumab has improved survival in metastatic lung cancer patients. The FDA approved the use of this drug in metastatic non-small cell lung cancer (NSCLC) based on an improvement in overall survival (OS) in an international, multicenter, open-label, randomized trial comparing nivolumab to docetaxel in patients with progression on or after platinum-based chemotherapy. The augmented immune response enabled by this kind of agents has led to a particular group of side effects called immune-related adverse events (irAEs). However, the toxicity profile of nivolumab was acceptable in clinical trials. We describe here the experience with nivolumab in NSCLC patients from an Oncologic Center of Argentina. Methods We included patients (pts) with NSCLC who received nivolumab in our Centre between Aug 2015 and May 2016. The adverse events were recorded from the patient chart and the responses were evaluated by the physician in charge and defined as: progression disease (PD), stable disease (SD), partial response (PR) or complete response (CR) according to RECIST 1.1 criteria. With this information, adverse events profile, objective response rate (SD+PR), time to progression and overall survival was evaluated. All patients who received at least one dose of Nivolumab were evaluated for toxicity and efficacy.Results 20 pts were included with a follow up of 7.13 m (r 0-17.5). 18 pts started nivolumab and 2 did not received it due to disease progression. 61% were women, 39% current smoker, 66% were non squamous lung cancer. Median of chemotherapy lines before nivolumab was 2 (r 0-6), and 76% received RDT pre-nivolumab. 89% progressed to platinum treatment. Time to pre immunotherapy treatment failure was 2.84 m (IC95% 0.57-5.11). Sites of relapse or progression before nivolumab were: lung (14), lymph nodes (8), bone (3), liver (2) and adrenal gland (1). 44% were PS 0 and 50% PS I. Number of nivolumab´s cycles was 7.5 (r 1-31). 41% presented adverse effect of any grade (g). 4 pts had hypotiroidism (g.2), 2 pyrexia, 1 diarrhea (g.1), 1 arthralgia (g.1), 1 astenia (g.2), 1 rash (g.1), 1 pneumonitis (g.3), 1 acute kidney failure (g.2). The objective response rate was evaluated in 13 pts. 8/13 (61%) had objective response (RC 1/13, PR 7/13), 2/13 had SD and 3/13 PD. Time to response was 4 m (IC95% 2.36-7.46), time to progression was 6.57 m. Sites of relapse or progression were lung (7 pts), bone (3 pts), brain (1 pts), node (2 pts). Conclusion In this real world experience Nivolumab was well tolerated, with manageable adverse effects and promising clinical outcomes.