Highlights
- •Durvalumab with chemoradiotherapy demonstrates the promising efficacy in LS-SCLC.
- •Durvalumab administered concurrently with radiotherapy was tolerable.
- •Prophylactic cranial irradiation demonstrated lower brain metastases rate.
- •The predictive role value of PD-L1 expression was insufficient.
Abstract
Background
The current standard treatment for limited-stage small-cell lung cancer (LS-SCLC)
is chemotherapy with concurrent chemoradiotherapy (CCRT).
Methods
In this single-arm phase II study, patients with LS-SCLC received four cycles of etoposide,
cisplatin, and durvalumab every 3 weeks. Thoracic radiotherapy of 52.5 Gy in 25 once-daily
fractions was started with the third cycle of chemoimmunotherapy. After CCRT plus
durvalumab, patients received durvalumab consolidation therapy every 4 weeks for a
maximum of 2 years after study enrolment. Prophylactic cranial irradiation (PCI) was
recommended.
Results
Fifty-one patients were enrolled, and 50 were included in the full analysis set. With
the median follow-up duration of 26.6 months, the median PFS was 14.4 months (95%
confidence interval: 10.3–NA), and the 24-month PFS rate was 42.0%. The median overall
survival was not reached with a 24-month overall survival rate of 67.8%. The positive
PD-L1 group (n = 22) was not associated with longer PFS (hazard ratio, 0.70; 0.31–1.58)
and overall survival (0.64; 0.22–1.84) compared with the negative PD-L1 group (n = 20).
Among the 43 patients who were candidates for PCI treatment, the PCI group (n = 22)
had significantly fewer events of brain metastasis as the first failure sites compared
to the no PCI group (n = 21) (13.6% vs. 42.9%, P = 0.033). There were several grade 3 or 4 adverse events which were well managed
with appropriate supportive care.
Conclusions
Durvalumab with CCRT for LS-SCLC exhibited promising clinical efficacy with a tolerable
safety profile, prompting its validation in a randomized study.
Trial registration
NCT03585998.
Keywords:
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Article info
Publication history
Published online: April 29, 2022
Accepted:
March 24,
2022
Received in revised form:
February 18,
2022
Received:
December 8,
2021
Identification
Copyright
© 2022 Elsevier Ltd. All rights reserved.
