Open AccessProposal of a Useful Surrogate Endpoint of the Overall Survival in Patients Undergoing Pulmonary Metastasectomy: The Time to Local Therapy Failure
Author(s) -
Kanzaki Ryu,
Kanou Takashi,
Ose Naoko,
Funaki Soichiro,
Minami Masato,
Tajima Testuya,
Fujii Makoto,
Ohno Yuko,
Shintani Yasushi
Publication year - 2019
Publication title -
world journal of surgery
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.115
H-Index - 148
eISSN - 1432-2323
pISSN - 0364-2313
DOI - 10.1007/s00268-019-05071-2
Subject(s) - medicine , surrogate endpoint , clinical endpoint , concordance , metastasectomy , cardiothoracic surgery , overall survival , surgery , clinical trial , cancer , metastasis
Background A recent study demonstrated remarkable discrepancy between the relapse‐free survival (RFS) and overall survival (OS) after pulmonary metastasectomy (PM) in the current era. As the RFS may not be a suitable parameter after PM, a more suitable parameter is needed for PM as a surrogate marker for OS. Methods A total of 134 consecutive patients who underwent PM were retrospectively analyzed. In the present study, we introduced a new endpoint, time to local treatment failure (TLTF). This endpoint was defined as the time interval between the first PM and the first untreatable recurrence by local treatment with curative intent or death due to any cause. We analyzed the correlation between the RFS and OS and between the TLTF and OS to validate whether or not the TLTF is a better parameter than the RFS after PM. Results Thus far, 78 patients have experienced relapse. Of these, 37 patients (47%) underwent local therapy with curative intent, 29 of whom are alive without local treatment failure. The 5‐year OS, RFS and TLTF were 70.9%, 36.5%, and 57.6%, respectively. The concordance proportions for the RFS and OS and for the TLTF and OS were 0.634 and 0.851 for all patients, respectively. The Spearman's rank correlation coefficient for the RFS and OS was 0.639, while that for the TLTF and OS was 0.875. Conclusions The TLTF may be a good surrogate parameter for the OS after PM in the current era.