Non-biological progression was assessed using CA 19-9 every 28 days until end of treatment, and was defined as a 2-month CA19.9 concentration lower than 1.5 times the baseline CA 19-9 concentration.

OS was was defined as the time from the inclusion to death due to any cause. Participants without documented death were censored at the date of the last follow-up or last patient contact. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.

Event-free survival (EFS) was defined as the delay between trial inclusion and the first of the following events: progression (biological or morphological), death, treatment interruption due to toxicity, initiation of another treatment. Morphological progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Biological progression is defined as a confirmed increase in CA 19-9 concentration to more than 1.5 times the baseline value, sustained over two consecutive monthly assessments.

Patients without any of the aforementioned events at the time of the statistical analysis will be censored at the time they were last known to be event-free. The EFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

Progression was defined as morphological or biological progression. Progression-free survival was defined as the delay between trial inclusion and progression (morphological or biological) or death for any reason. Morphological progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Biological progression is defined as a confirmed increase in CA 19-9 concentration to more than 1.5 times the baseline value, sustained over two consecutive monthly assessments. Patients who have not progressed nor died at the time of the statistical analysis will be censored at the time they were last known to be progression-free. The EFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions to evaluate quality of life. The first 28 use a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) assessing 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea/vomiting, pain), six single symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties), and two global health/QoL questions. Items 29 and 30 use a 7-point scale (1=very poor to 7=excellent).Scores are linearly transformed from 0 to 100 per EORTC guidelines. Higher scores mean better functioning or QoL for functional/global scales, but worse symptoms for symptom scales and items. Score ranges (0-100): higher Functional scores = better QoL; higher Symptom scores= worse QoL; Higher Global health score= better QoL.

Non-progression is defined as partial response, complete response or stable disease according to RECIST V1.0. Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).Stable disease is defined as no decrease or increase sufficient to qualify as partial response or progression with reference to SLD since the start of treatment. Radiologic assessment was carried out every 8 weeks.

8 patients deceased at 4 months

Non-biological progression was assessed using CA 19-9 every 28 days until end of treatment, and was defined as a 2-month CA19.9 concentration lower than 1.5 times the baseline CA 19-9 concentration.

5 patients deceased at 2 months

OS was was defined as the time from the inclusion to death due to any cause. Participants without documented death were censored at the date of the last follow-up or last patient contact. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.

Event-free survival (EFS) was defined as the delay between trial inclusion and the first of the following events: progression (biological or morphological), death, treatment interruption due to toxicity, initiation of another treatment. Morphological progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Biological progression is defined as a confirmed increase in CA 19-9 concentration to more than 1.5 times the baseline value, sustained over two consecutive monthly assessments.

Patients without any of the aforementioned events at the time of the statistical analysis will be censored at the time they were last known to be event-free. The EFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

Progression was defined as morphological or biological progression. Progression-free survival was defined as the delay between trial inclusion and progression (morphological or biological) or death for any reason. Morphological progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Biological progression is defined as a confirmed increase in CA 19-9 concentration to more than 1.5 times the baseline value, sustained over two consecutive monthly assessments. Patients who have not progressed nor died at the time of the statistical analysis will be censored at the time they were last known to be progression-free. The EFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions to evaluate quality of life. The first 28 use a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) assessing 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea/vomiting, pain), six single symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties), and two global health/QoL questions. Items 29 and 30 use a 7-point scale (1=very poor to 7=excellent).Scores are linearly transformed from 0 to 100 per EORTC guidelines. Higher scores mean better functioning or QoL for functional/global scales, but worse symptoms for symptom scales and items. Score ranges (0-100): higher Functional scores = better QoL; higher Symptom scores= worse QoL; Higher Global health score= better QoL.