Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer

Susan Kellum, Mercer University College of Pharmacy

According to the American Cancer Society (ACS), around 85-90% of lung cancer cases are non-small cell lung cancer (NSCLC) which consists of various subtypes. 1 In nonsquamous NSCLC, treatment options have shown to be limited when the disease progresses after first-line chemotherapy. 2 Docetaxel was approved as a second-line treatment for advanced or metastatic non-small cell lung cancer (NSCLC) in patients who have failed prior platinum-based chemotherapy on the basis of longer survival versus supportive care. 3 In a new study, researchers compared the efficacy of nivolumab to that of docetaxel in patients with NSCLC that had progressed either during or after receiving platinum-based chemotherapy.

Title: Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer2
Design Randomized, open-label, international phase three study (N = 582)
Objective To assess efficacy and safety of nivolumab in increasing survival rate compared to docetaxel
Study Groups Nivolumab (n = 292)

Docetaxel (n = 290)

Methods Patients were randomly assigned to receive nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks, or docetaxel at a dose of 75 mg per square meter of body-surface area every three weeks administered intravenously. A median of six doses of nivolumab and four doses of docetaxel were administered. Among the patients in the docetaxel group, 66% received at least 90% of the planned dose intensity. At least one dose delay occurred in 39% of the patients in the nivolumab group and in 37% of those in the docetaxel group.
Duration November 2012 through December 2013
Primary Outcome Measure Overall survival
Baseline Characteristics The median age of the patients was 62 years. Most patients had an Eastern Cooperative Oncology Group (ECOG) performance-status score of one, have stage IV cancer, and were current or former smokers. The baseline characteristics were balanced between the treatment groups.
Results  

Median overall survival:

Nivolumab group = 12.2 months (95% confidence interval [CI], 9.7 to 15.0)

Docetaxel group = 9.4 months (95% CI, 8.1 to 10.7)

There was a 27% lower risk of death with nivolumab (hazard ratio, 0.73; 96% CI, 0.59 to 0.89; P=0.002).

Overall survival rate at 1 year:

Nivolumab group = 51% (95% CI, 45 to 56)

Docetaxel group = 39% (95% CI, 33 to 45)

Adverse Events
Common Adverse Events:
Nivolumab group (% of patients): fatigue (16), nausea (12), decreased appetite (10), asthenia (10)

Docetaxel group (% of patients): neutropenia (31), fatigue (29), nausea (26), and alopecia (25)

 

Serious Adverse Events:

Nivolumab group (7% of patients)

Docetaxel group ( 20% of patients)

Percentage that Discontinued due to Adverse Events:

Nivolumab group (5% of patients)

Docetaxel group (15% of patients)

Study Author Conclusions Among patients with advanced nonsquamous NSCLC that had progressed during or after platinum-based chemotherapy, overall survival was longer with nivolumab than with docetaxel.

All patients who underwent randomization were treated until the disease progression or discontinuation of treatment due to toxic effects or other reasons. Randomization was stratified according to prior maintenance treatment (yes vs. no) and line of therapy (second line vs. third line). Patients were followed for survival continuously while receiving treatment and every three months after the discontinuation.

Subsequent systemic cancer therapy was received by 42% of the patients in the nivolumab group and by 50% of those in the docetaxel group. In the nivolumab group, 23% of the patients received subsequent docetaxel; 2% of the docetaxel group received subsequent immunotherapy.

References

  1. American Cancer Society. What is non-small cell lung cancer? http://www.cancer.org. Accessed 29 September 2015
  2. Borghaei H, Paz-ares L, Horn L, et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015
  3. Taxotere® (docetaxel). [Package Insert]. Bridgewater, NJ: Sanofi-aventis, LLC; 2010.
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