Electronic patient-reported outcome measured in patients with pancreatic cancer receiving second-line chemotherapy: A multicenter prospective observational study.
Authors: Ohba Akihiro , Takumoto Yuki , Terashima Takeshi , Ueno Makoto , Kobayashi Satoshi , Ikezawa Kenji , Okano Naohiro , Fujimori Nao , Tsumura Hidetaka , Murohisa Go , Ohya Ayano , Yamashita Tatsuya , Ozaka Masato , Ikeda Masafumi , Okusaka Takuji , Morizane Chigusa , Narimatsu Hiroto , Akazawa Manabu , Shiroiwa Takeru , Furuse Junji 
Published: January 2023

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Background: Pancreatic cancer and especially late-line chemotherapy often negatively impact patient quality of life (QoL). However, QoL outside of the date of hospital visits has not been adequately evaluated. This study assessed QoL at home in patients receiving chemotherapy using electronic patient-reported outcomes (ePRO). Methods: This multicenter prospective observational study was conducted in 29 Japanese centers. Pathologically confirmed unresectable pancreatic cancer patients who were going to receive a second cycle of second-line chemotherapy, liposomal irinotecan plus fluorouracil/leucovorin (nal-IRI+FF), gemcitabine plus nab-paclitaxel (GEM+nab-PTX), or gemcitabine alone (GEM) at the outpatient department were included. QoL was assessed by electronic instruments on days 1, 2, 4, 6, 8, and 11 of each administration during two consecutive cycles (second and third cycles). The primary outcome was the index value of EuroQol 5-dimensions 5-levels (EQ-5D-5L). Secondary outcomes were the status of the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30 and Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE). Results: A total of 90 patients, 56 receiving nal-IRI+FF, 27 receiving GEM+nab-PTX, and 7 receiving GEM, were eligible for this study. The patients who responded to at least the first questionnaire and received nal-IRI+FF (n = 46) or GEM+nab-PTX (n = 16) were selected for analysis. In the nal-IRI+FF group, the mean index value of EQ-5D-5L on day 1 of the second cycle was 0.803±0.142, declined up to day 6 (0.678±0.247), and had recovered by day 1 of the third cycle (0.776±0.197). Similar trends were observed in the third cycle; the nadir of the mean index value was 0.723±0.182 on day eight and had recovered by day 15 (0.782±0.159). On the other hand, in the GEM+nab-PTX group, the nadir of the mean index value in the second cycle was on day 6 of the third administration (0.751±0.184) and had not fully recovered by day 1 of the third cycle (0.789±0.182). For global health status according to EORTC-QLQ-C30, a similar trend to EQ-5D-5L was observed in both groups. According to the results of the PRO-CTCAE, pain (40.4%), diarrhea (36.5%), abdominal pain (30.8%), fatigue (28.8%), and anorexia (28.8%) were frequent severe or very severe adverse events in the nal-IRI+FF group. In comparison, diarrhea (29.2%) and anorexia (25.0%) were frequent severe or very severe adverse events in the GEM+nab-PTX group. Conclusions: QoL assessed by ePRO outside the date of hospital visits revealed the pattern or details of QoL transition. Further study is needed so that these trends can be taken into account in the management of chemotherapy. Clinical trial information: UMIN000044245 .