Applicability of the PACIFIC trial results in patients not eligible for the PACIFIC trial: Canadian rapid consensus statement and recommendations.
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BACKGROUND: The PACIFIC study established durvalumab as a standard of care for consolidation therapy in patients treated with radical intent chemoradiation for stage III inoperable non-small cell lung cancer. In clinical practice, many patients are not eligible for trials, yet radical intent chemoradiation may still be used. METHODS: A virtual anonymous tumour board Delphi-model was used in order to generate consensus on the use of durvalumab in six clinical situations where chemoradiation is used in clinical practice and recommended in guidelines, yet not PACIFIC eligible. Two anonymous iterations were sent and recommendations were circulated for approval and comment. Results are presented using a modified PICOT format (patients, intervention, control, outcomes, and ongoing trials). RESULTS: In three of the scenarios, consensus was reached and recommendations were for the use of consolidation durvalumab, but being respectful of potentially increased toxicity/reduced benefit in comparison to PACIFIC results (treatment of stage IIB inoperable, recurrent mediastinal disease, and residual gross disease post attempted surgical removal). There was a recommendation against using durvalumab in resected stage III disease with R1 or R0 margins, even if chemoradiation were considered. There was not consensus on the use of consolidation durvalumab in the setting of oligometastatic disease or in the setting of large cell neuroendocrine carcinoma or combined small cell carcinoma. CONCLUSION: Treatment of 'real-world' lung cancer often involves chemoradiation in settings outside of stage III and eligible for the PACIFIC study. This paper offers recommendations in these scenarios based on a consensus approach.
