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Quality of life, long-term survivors and long-term outcome from the ABC-02 study.

ABSTRACT: The ABC-02 (Advanced Biliary Tract Cancer) study established cisplatin and gemcitabine (CisGem) as the standard first-line chemotherapy for patients with locally advanced or metastatic biliary tract cancer (BTC). We examine quality of life (QoL), describe the long-term survivors and provide a long-term outcome.A total of 410 BTC patients were randomised to receive either CisGem or gemcitabine alone (Gem); 324 patients consented to complete EORTC QLQ-C30 and EORTC QLQ-PAN26 QoL questionnaires; 268 (83%) patients returned at least one QoL questionnaire (134 in each arm). Long-term survivors were defined as those surviving over 2 years and we performed a final analysis of the primary outcome; overall survival (OS).Most QoL scales showed a trend favouring the combined CisGem arm, including functional and symptomatic scales, although the differences were not statistically significant. Forty-five (11%)) patients survived at least 2 years (34 received CisGem and 11 Gem) and 21 (5%) 3 years or more (14 received CisGem and 7 Gem). After a median follow-up of 9.2 months and 398 deaths, the median OS was 11.7 months for CisGem and 8.1 months for Gem (hazard ratio (HR)=0.65, 95% CI: 0.53-0.79, P<0.001).The survival advantage of CisGem compared to Gem was not associated with an improvement or deterioration of QoL. Long-term survivors were more likely to have received CisGem and the long-term OS is identical to that previously described.

SUBMITTER: Bridgewater J

PROVIDER: S-EPMC4984909 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Quality of life, long-term survivors and long-term outcome from the ABC-02 study.

Bridgewater John J Lopes Andre A Palmer Daniel D Cunningham David D Anthoney Alan A Maraveyas Anthony A Madhusudan Srinivasan S Iveson Tim T Valle Juan J Wasan Harpreet H

British journal of cancer 20160401 9

<h4>Background</h4>The ABC-02 (Advanced Biliary Tract Cancer) study established cisplatin and gemcitabine (CisGem) as the standard first-line chemotherapy for patients with locally advanced or metastatic biliary tract cancer (BTC). We examine quality of life (QoL), describe the long-term survivors and provide a long-term outcome.<h4>Methods</h4>A total of 410 BTC patients were randomised to receive either CisGem or gemcitabine alone (Gem); 324 patients consented to complete EORTC QLQ-C30 and EOR ...[more]

PMID: 27115567

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Project description:BackgroundCompared to other life-threatening infection survivors, long-term health-related quality of life (QOL) of patients surviving necrotizing soft-tissue infections (NSTI) and its determinants are little known. In this monocentric prospective cohort including NSTI survivors admitted between 2014 and 2017, QOL was assessed during a phone interview using the 36-Item Short-Form Health Survey (SF-36), the Hospital Anxiety and Depression (HAD), the activity of daily living (ADL), instrumental ADL (IADL) scales and the Impact of Event Scale-Revised (IES-R). The primary outcome measure was the SF-36 physical component summary (PCS). NSTI patients were compared according to intensive care unit (ICU) admission status. ICU survivors were matched on SAPS II with non-NSTI related septic shock survivors.ResultsForty-nine NSTI survivors were phone-interviewed and included in the study. Median PCS was decreased compared to the reference population [- 0.97 (- 2.27; - 0.08) SD]. Previous cardiac disease was the only variable associated with PCS alteration [multivariate regression coefficient: - 8.86 (- 17.64; - 0.07), p = 0.048]. Of NSTI survivors, 15.2% had a HAD-D score ≥ 5 and 61.2% an IES-R score ≥ 33. ICU admission was not associated with lower PCS [35.21 (25.49-46.54) versus (vs) 41.82 (24.12-51.01), p = 0.516], but with higher IES-R score [14 (7.5-34) vs 7 (3-18), p = 0.035] and a higher proportion of HAD-D score ≥ 5 (28.6 vs 4.0%, p = 0.036). Compared to non-NSTI septic shock-matched controls, NSTI patients had similar PCS [33.81 (24.58; - 44.39) vs 44.87 (26.71; - 56.01), p = 0.706] but higher HAD-D [3.5 (1-7) vs 3 (1.5-6), p = 0.048] and IES-R scores [18 (8-35) vs 8 (3-19), p = 0.049].ConclusionsLong-term QOL in NSTI survivors is severely impaired, similarly to that of non-NSTI septic shock patients for physical compartments, but with more frequent depressive and/or post-traumatic stress disorders. Only ICU admission and previous cardiac disease were predictive of QOL impairment.

Project description:Background: Open abdomen treatment (OAT) is widely accepted to manage severe abdominal conditions such as peritonitis and abdominal compartment syndrome but can be associated with high morbidity and mortality. The main risks in OAT are (1) entero-atmospheric fistula (EAF), (2) failure of primary fascial closure, and (3) incisional hernias. In this study, we assessed the long-term functional outcome after OAT to understand which factors impacted most on quality of life (QoL)/daily living activities and the natural course after OAT. Materials and Methods: After a retrospective analysis of 165 consecutive OAT patients over a period of 10 years (2002-2012) with over 65 clinical parameters that had been performed at our center (1), we initiated a prospective structured follow-up approach. All survivors were invited for a clinical follow-up. Forty complete datasets including clinical and social follow-up with SF-36 scores were available for full analysis. Results: The patients were dominantly male (75%) with a median age of 52 years. Primary fascial closure (PC) was achieved in 9/40 (23%), while in 77% a planned ventral hernia (PVH) approach was followed. A total of 3/4 of the PVH patients underwent a secondary-stage abdominal wall reconstruction (SSR), but 2/3 of these reconstructed patients developed recurrent hernias. Fifty-five percent of the patients with PC developed an incisional hernia, while 20% of all patients developed significant scarring (Vancouver Scar Score >8). Scar pain was described by 15% of the patients as "moderate" [Visual Analog Scale (VAS) 4-6] and by 10% as "severe" (VAS > 7). While hernia presence, PC or PVH, and scarring showed no impact on QoL, male sex and especially EAF formation significantly reduced QoL. Discussion: Despite many advantages, OAT was associated with relevant mortality and morbidity, especially in the early era before the implementation of a structured concept at our center. Follow-up revealed that hernia incidence after OAT and secondary reconstruction were high and that 25% of patients qualifying for a secondary reconstruction either did not want surgery or were unfit. Sex and EAF formation impacted significantly on QoL, which was lower than in the general population. With regard to hernia incidence, new strategies such as prophylactic mesh implantation upon fascial closure should be discussed analogous to other major abdominal procedures.

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Project description:Parents of children with cancer desire information regarding the late effects of treatment. In the current study, the authors assessed parents' preparedness for late effects at least 5 years after their child's diagnosis.A cross-sectional survey was conducted of all eligible parents of children with cancer between April 2004 and September 2005 at Dana-Farber/Boston Children's Cancer and Blood Disorders Center within 1 year of diagnosis, and a follow-up questionnaire was administered at least 5 years later.Approximately 66% of parents of children who were still living, and who were able to be contacted, completed the follow-up questionnaire (91 of 138 parents). Approximately 77% of respondents (70 of 91 respondents) were parents of disease-free survivors and 23% (21 of 91 respondents) were parents of children with recurrent disease. The majority of parents believed they were well prepared for their child's oncology treatment (87%), but fewer felt prepared for future limitations experienced by their children (70%; P = .003 using the McNemar test) or for life after cancer (62%; P<.001). On bivariable analysis among parents of disease-free survivors, parents were more likely to believe themselves to be prepared for future limitations when they also reported that communication with the oncologist helped to address worries regarding the future (odds ratio, 4.50; P = .01). At the time of diagnosis, both parents and physicians underestimated a child's risk of future limitations; 45% of parents and 39% of clinicians predicted future limitations in physical abilities, intelligence, or quality of life, but at the time of the follow-up questionnaire >5 years later, 72% of children experienced limitations in at least 1 domain.Parents believe themselves to be less prepared for survivorship than for treatment. High-quality communication may help parents to feel more prepared for life after cancer therapy. Cancer 2016;122:2587-94. © 2016 American Cancer Society.

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Quality of life, long-term survivors and long-term outcome from the ABC-02 study.

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Quality of life, long-term survivors and long-term outcome from the ABC-02 study.

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