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The PACIFIC model has become the standard of care for patients with stage III unresectable non-small cell lung cancer, but in clinical practice, due to concerns about the safety of concurrent chemoradiotherapy, the proportion of patients choosing sequential chemoradiotherapy mode is high
.
Therefore, it is unclear
whether immunomaintenance therapy following sequential chemoradiotherapy also confers a survival benefit for patients.
Recently, JTO published data from the PACIFIC-6 study exploring the feasibility
of maintenance therapy with duvalumab after sequential chemoradiotherapy.
Background:
Based on the phase III PACIFIC study, for patients with inoperable stage III non-small cell lung cancer, the disease has not progressed after receiving concurrent chemoradiotherapy, and 12 months of maintenance therapy with duvalumab is the current standard ofcare.
For patients with stage III inoperable non-small cell lung cancer, concurrent chemoradiotherapy has a better local control rate
than sequential chemoradiotherapy.
However, in clinical practice, most patients may choose sequential chemoradiotherapy
for safety reasons.
Therefore, this study aimed to explore whether patients who do not progress after sequential chemoradiotherapy could benefit
from maintenance therapy with duvalumab.
Method:
The PACIFIC-6 study is a multicenter, open-label, single-arm Phase II clinical study.
Patients with stage III inoperable non-small cell lung cancer confirmed by histopathology were enrolled in patients who met the inclusion criteria received sequential chemoradiotherapy and at least two cycles of chemotherapy at a dose of 60 Gy±10
.
Radiation therapy
is started within 6 weeks after the end of chemotherapy.
The therapeutic dose of duvalumab is 1500 mg every 4 weeks for 24 months, or disease progression and intolerable adverse effects
.
The primary endpoints were grade 3 or more treatment-related adverse effects over six months, and secondary endpoints included progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and overall survival (OS).
Outcome:
General characteristicsBetweenApril 2019 and December 2020, a total of 117 patients
from 25 research centers in 6 countries were included.
The median age of the patients was 68 years, 62.
4% were male, 61.
5% were diagnosed with stage IIIb or IIIc, and 53.
8% had adenocarcinoma
.
Patients with PS scores of 0 and 1 were 40.
2% and 57.
3%,
respectively.
The median number of chemotherapy treatment cycles was 4 cycles, and vinorelbine and paclitaxel were the most common chemotherapy drugs, accounting for 26.
5% and 19.
7%
respectively.
The median time from the end of chemotherapy to the start of radiotherapy was 26 days, and 95.
7% of patients started immunotherapy 14 days after the end of radiotherapy
.
At the time of data analysis, the median follow-up was 12.
9 months
.
Safety results94.
9
% of patients experienced all-due adverse reactions of any grade, and 18.
8% (22 patients) of patients discontinued
treatment due to grade 3 or higher adverse reactions.
The most common causes of treatment interruption were pneumonia (6.
8%), fever (6.
8%), and dyspnea (5.
1%)
.
The incidence of serious adverse reactions was 19.
7%, of which 1.
7% of patients experienced grade 5 adverse reactions
.
When analyzing efficacy analysis
, the median PFS was 10.
9 months and the PFS rate at 12 months was 49.
6% (Fig.
1).
The OS rates at 12 and 24 months were 84.
1% and 69.
8%, respectively (Figure 2).
The patient ORR was 17.
1%, and the median DOR had not yet been reached
.
Figure 1 PFS Analysis Figure 2 OS Analysis
In the exploratory analysis, PD-L1 expression was ≥1% and <1% in 51.
4% and 48.
6% of patients, median PFS in the two groups were 13.
6 and 10.
9 months, PFS rates at 12 months were 54.
8% and 49.
4%, 12-month OS rates were 91.
5% and 77.
4%, 24-month OS rates were 60.
2% and 70.
3%, and ORRs were 19.
4% and 11.
8%, respectively.
Patients with high PD-L1 expression have a better trend<b20> of benefit.
conclusion
Receiving duvolimumab after sequential chemoradiotherapy has a manageable safety profile and shows good antitumor activity.
For patients who are not candidates for concurrent chemoradiotherapy, sequential chemoradiotherapy followed by duvalumab is also a reasonable treatment strategy
.
References: Garassino MC, Mazieres J, Reck M, et al.
Durvalumab After Sequential Chemoradiotherapy in Stage III, Unresectable NSCLC: The Phase 2 PACIFIC-6 Trial, Journal ofThoracic Oncology (2022), doi: https://doi.
org/10.
1016/j.
jtho.
2022.
07.
1148.
Review: Xiaoyuan Typesetting: Xiaoyuan Execution: Xiaoyuan
