GENEVA — Two immunotherapies recently approved for the treatment of advanced non–small cell lung cancer (NSCLC) achieve outcomes in the real world that are comparable to those reported from clinical trials, say researchers from Israel.
Outcomes were not affected by the presence of brain or liver metastases or the number of previous treatments, the researchers noted.
However, the naturalistic analysis of the performance of the programmed cell death (PD) inhibitors nivolumab (Opdivo, Bristol-Myers Squibb Company) and pembrolizumab (Keytruda, Merck Sharp & Dohme Corp) also showed that survival is significantly affected by patients' performance status.
The new findings come from a cohort of 87 patients treated at Davidoff Cancer Center, Petah Tikva, Israel, and were presented Elizabeth Dudnik, MD, in a poster session here at European Lung Cancer Conference (ELCC) 2016.
Earlier at the meeting, the value of observational data in support of clinical decision making was highlighted by Suresh Senan, MD, PhD, vice chair of the Department of Radiation Oncology at the VU University Medical Centre in Amsterdam, the Netherlands, when he received the Heine H. Hansen Award earlier this week.
As reported by Medscape Medical News, he urged clinicians to look beyond randomized controlled trials to observational and registry data to inform decision making.
Dr Dudnik said that she "strongly agrees" with that notion, particularly insofar as randomized controlled trials typically do not include patients who are seen regularly in clinics.
"All the poor-prognosis patients are underrepresented in the clinical trials because the clinical trials just have the 'good' patients, with an ECOG [Eastern Cooperative Oncology Group] performance status of 0-1, no patients with brain metastases, and probably these are patients that are younger," she told Medscape Medical News.
"It's not our cohort. Our cohort is a poor-prognosis cohort, with 50% of our patients with a poor ECOG performance, at 2 and above, and 20% of our patients had liver and brain metastases," she said.
The data on the efficacy and safety of nivolumab and pembrolizumab that come from the clinical trials that were used for approval are not that helpful to this "real-world setting," she said.
Study Details
Dr Dudnik and colleagues studied 87 consecutive patients with advanced NSCLC who were given intravenous nivolumab 3 mg/kg q3 weeks (n = 85) or pembrolizumab 2 mg/kg q3 weeks (n = 2) between February 2015 and January 2016, either as standard-of-care treatment or on a compassionate use basis.
The median age of the patients was 67 years, and 68% were men. Fifty two percent of patients had an ECOG performance status (PS) of 0/1; the remaining 48% had a PS of 2/3. Liver metastases were present in 23% of patients, and 21% had brain metastases.
It is noteworthy that 59% of patients had undergone one previous treatment, 25% had had two previous treatments, and 16% had had at least three prior treatments.
These patients received a median of five treatment cycles. The median duration of follow-up was 10 weeks; 56 patients could be evaluated for their response to treatment.
An overall objective response rate, defined using the Response Evaluation Criteria in Solid Tumors guideline version 1.1, was 28%, with all responders continuing to respond to treatment.
Progression was seen in 45% of patients; 30% died during follow-up. The latest data projection suggests that median progression-free survival is 13 weeks. The median overall survival has not been reached.
During follow-up, one patients with Crohn's disease developed grade 5 neutropenia, one patient developed grade 5 hepatitis, and two patients developed grade 3 pneumonitis. No other major adverse events were recorded.
On multivariate analysis that took into account age, sex, smoking status, tumor histology, brain or liver metastases, and previous treatment, only ECOG performance status 2/3 vs 0/1 was significantly associated with progression-free survival and overall survival, at odds ratios of 3.19 and 6.53, respectively.
Dr Dudnik observed that the current finding that the number of prior treatments does not affect outcomes replicates the phase 1 trial data for nivolumab. This suggests, she said, that "probably you can use this treatment as a third- and fourth-line therapy and get the same results."
BMS and MSD provided nivolumab and pembrolizumab for patients; no research funding or other form of support was received from the pharmaceutical company. Dr Dudnik received honoraria for lectures from MSD, and several coauthors also received honoraria.
European Lung Cancer Conference (ELCC) 2016: Poster 181P, presented April 14, 2016.
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