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Nedaplatin, docetaxel improve OS in advanced, relapsed squamous NSCLC
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Treatment with nedaplatin and docetaxel produced significantly longer OS compared with cisplatin and docetaxel in patients with advanced or relapsed squamous cell lung cancer, according to the results of a randomized phase 3 trial.
Based on these data, nedaplatin (Aqupla, Shionogi & Co.) and docetaxel may serve as a new viable treatment option for advanced or relapsed squamous cell lung cancer, according to the researchers.
“Squamous histology accounts for 20% to 30% of lung cancer cases,” Nobuyuki Yamamoto, MD, PhD, professor of internal medicine at Wakayama Medical University in Japan, and colleagues from the West Japan Oncology Group, wrote. “Limited progress has been made in the treatment of advanced squamous cell lung cancer compared with that in non-squamous, non–small cell lung cancer.”
Nedaplatin — a cisplatin derivative — plus docetaxel demonstrated promise in phase 1 and phase 2 studies of patients with advanced squamous cell lung cancer, according to study background. Nedaplatin was develop to decrease the toxicity associated with cisplatin, and treatment with nedaplatin does not require hydration for renal protection.
Thus, Yamamoto and colleagues conducted an open-label study comparing nedaplatin and docetaxel with cisplatin and docetaxel in Japanese patients with previously untreated advanced or relapsed squamous cell lung cancer.
The researchers randomly assigned 349 patients to 60 mg/m2 docetaxel with IV nedaplatin (100 mg/m2; n = 177) or cisplatin (80 mg/m2; n = 172) every 3 weeks for four to six cycles.
OS served as the primary endpoint. Safety served as a secondary endpoint.
Median follow-up was 39.3 months (interquartile range, 31.3-48.7).
At the time of reporting, 307 patients had died (nedaplatin, n = 153; cisplatin, n = 154). Patients assigned nedaplatin achieved significantly longer median OS compared with patients assigned cisplatin (13.6 months vs. 11.4 months; P = .037).
The researchers observed differing safety profiles in the two treatment regimens. More patients assigned cisplatin experienced grade 3 or worse nausea (n = 25 vs. 7), fatigue (n = 20 vs. 6), hyponatremia (n = 53 vs. 24) and hypokalemia (n = 15 vs. 4), whereas more patients assigned nedaplatin experienced leucopenia (n = 98 vs. 77), neutropenia (n = 146 vs. 123) and thrombocytopenia (n = 16 vs. 0).
Seven patients died due to treatment-related adverse events (nedaplatin, n = 4; cisplatin, n = 3).
The researchers acknowledged limitations of their study, including the enrollment of only Japanese patients and the use of one-sided testing to determine OS. Further, the researchers noted that their study lacked a quality-of-life assessment.
“Nedaplatin plus docetaxel could be a new treatment option for advanced or relapsed squamous cell lung cancer,” Yamamoto and colleagues wrote. “Further investigation is needed to elucidate the mechanism of sensitivity of squamous cell lung cancer to nedaplatin and to determine predictive biomarkers for the drug’s efficacy.”
In an accompanying editorial, Yin Wu, MRCP, PhD, and James Spicer, PhD, both of Guy’s Hospital at King’s College London, wrote that despite the positive study results, further research is needed to determine the optimal use of nedaplatin.
“The [researchers] are right to conclude that nedaplatin can be thought of as a new treatment option for advanced or relapsed squamous NSCLC in the population that they studied, but more clinical data are needed before adoption of the drug as the new platinum standard worldwide,” Wu and Spicer wrote. “In reality, the desired step change in the poor outcomes that most people with advanced NSCLC still have is more likely to come from non-cytotoxic drugs. The spotlight now falls on further development of novel therapies directed at the various molecular targets already identified in this disease, and on immunotherapy.” – by Cameron Kelsall
Disclosure: Sanofi provided partial funding for this study. Yamamoto reports no relevant financial disclosures. Other study researchers report personal fees from Sanofi and grants from Nippon Kayaku. Wu and Spicer report no relevant financial disclosures.
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