medwireNews: Individuals with limited-stage small-cell lung cancer (SCLC) could benefit from the addition of durvalumab to chemoradiotherapy (CRT), suggest early data.
The combination “exhibited promising clinical efficacy with a tolerable safety profile,” say Jong-Mu Sun (Samsung Medical Center, Seoul, Republic of Korea) and co-researchers in the European Journal of Cancer.
In the single-center, phase 2 study, 50 patients who had not received prior treatment for limited-stage SCLC were given four 3-weekly cycles of durvalumab 1500 mg (day 1) plus etoposide 100 mg/m2 (days 1–3) and cisplatin 70 mg/m2 (day 1), with chest RT at a dose of 52.5 Gy in 25 once-daily fractions initiated with the third cycle. Patients without disease progression after completion of CRT continued to receive consolidation durvalumab 1500 mg every 4 week for up to 2 years.
After a median follow-up of 26.6 months, the median progression-free survival (PFS) was 14.4 months, while the median overall survival (OS) was not reached.
The 24-month PFS and OS rates were 42.0% and 67.8%, respectively, and these were significantly higher than the corresponding rates for the historic control group of patients who received a similar CRT regimen but not durvalumab, at 24.0% and 56.0%.
The investigators point out, however, that “[a]lthough the main chemotherapy regimens are similar between [the] two groups, there are improvements in supportive care, imaging modalities, or radiotherapy in the study arm, as times of more than 10 years have passed since the historical control population was treated.”
They therefore caution that “the advance in practical medicine should be considered in the interpretation of our results.”
The team also assessed survival outcomes by PD-L1 status in 42 participants with available data, and found that the 24-month PFS and OS rates were numerically higher for those with PD-L1-positive versus negative tumors (combined positive score ≥1 vs <1), but there was “no significant difference in survival” between the subgroups.
With regard to the safety profile, Sun and colleagues note that “the frequency and severity of adverse events [AEs] were [as] expected.”
The most common AE was chemotherapy-related neutropenia, occurring at grade 2 in 8% of patients, grade 3 in 34%, and grade 4 in 56%. Neutropenic fever of grade 3 occurred in 18% of participants.
Several patients experienced grade 3 or 4 immune-related AEs, including one patient who had grade 4 hepatitis and lipase elevation as well as grade 3 amylase elevation, all of which resolved after steroid therapy. Four patients discontinued durvalumab due to immune-related AEs.
“[T]hese data strongly suggest the necessity of a randomized trial to validate the efficacy of durvalumab plus [concurrent] CRT in patients with [limited-stage]-SCLC,” concludes the research team.
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