2.2. Anthropometric and Clinical Parameters

A literature review identified the known prognostic factors for overall survival in first-line mPC [7]. The clinical, tumor, and biological criteria were collected at inclusion, during visits for each chemotherapy cycle, and during tumor evaluations. At the time of inclusion, the clinical criteria were as follows: sex, age, the type of chemotherapy received, ECOG PS, weight, and body mass index (normalized weight squared, BMI). The tumor criteria were as follows: tumor location and the presence of hepatic, peritoneal, pulmonary, and other metastases. The biological criteria were CA19-9, CEA, and albumin levels, which were standardized to the standard of each laboratory.

The clinical data collected during tumor evaluation were as follows: ECOG PS, weight loss since inclusion, and BMI. The patient quality of life data were measured using version 3 of the Quality of Life Core Questionnaire (QLQ-C30) of the European Organization for Research and Treatment of Cancer [15] to evaluate the quality of life in the previous seven days. In our study, the questionnaire was analyzed in accordance with the EORTC guidelines [16]. The analysis focused on the scales that are generally most affected in patients with pancreatic cancer: the global health status and the quality of life scale, as well as other scales, namely fatigue, pain, physical functioning, emotional functioning, role functioning, cognitive functioning, social functioning, and financial difficulties. The most frequent symptoms reported in the questionnaire were dyspnea, insomnia, loss of appetite, constipation, and diarrhea. We used the thresholds defined in the initial quality of life analysis of the PRODIGE4/ACCORD11 study [3,14]. These thresholds were ≤33, 34–66, and ≥67 if enrolment was sufficient (at least 30 assessments for each class); otherwise, they were grouped into two categories. The collected biological data included tumor marker levels (CA19-9 and CEA). They were normalized to the standards of each laboratory. The variation since inclusion was also considered. The data on liver markers, such as total bilirubin, transaminases, and gamma-glutamyl transferase, were also collected and expressed as higher or lower than the standard of each laboratory.

The data on toxicities during treatment were also collected based on the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 [17]. All toxicities were recorded at the follow-up visits for each chemotherapy cycle every 14 days. For each patient, we considered the highest toxicities that occurred between each tumor evaluation. The occurrence of at least one hematological toxicity of grade 2 or grade ≥ 3 during the two months before each tumor evaluation was analyzed. The occurrence of hematological toxicity with grade 2 or grade ≥ 3 could require a treatment delay until a return to grade 1 for the first episode, dose reduction for the second episode, and discontinuation of treatment for the third episode. The occurrence of at least one non-hematological toxicity (other toxicities) of any grade during the two months before tumor evaluation was also analyzed.

Tumor progression was monitored using CT scans every two months, with three successive CT scans from the initiation of treatment for the first six months of treatment. The progression was defined according to the RECIST criteria (version 1.0) [5].