Health-Related Quality of Life After Cytoreductive Surgery/HIPEC for Mucinous Appendiceal Cancer: Results of a Multicenter Randomized Trial Comparing Oxaliplatin and Mitomycin

Background This study evaluated health-related quality of life (HRQOL) using patient-reported outcomes in subjects with mucinous appendiceal neoplasms who underwent cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) as part of a randomized trial comparing mitomycin wi...

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Published in:	Annals of surgical oncology Vol. 27; no. 3; pp. 772 - 780
Main Authors:	Moaven, Omeed, Votanopoulos, Konstantinos I., Shen, Perry, Mansfield, Paul, Bartlett, David L., Russell, Greg, McQuellon, Richard, Stewart, John H., Levine, Edward A.
Format:	Journal Article
Language:	English
Published:	Cham Springer International Publishing 01.03.2020 Springer Nature B.V
Subjects:	Adenocarcinoma, Mucinous - secondary Adenocarcinoma, Mucinous - therapy Adult Aged Aged, 80 and over Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use Appendiceal Neoplasms - pathology Appendiceal Neoplasms - therapy Appendix Cancer Chemotherapy Combined Modality Therapy Cytoreduction Surgical Procedures Female Gastrointestinal cancer Health Status Humans Hyperthermia, Induced Male Medicine Medicine & Public Health Middle Aged Mitomycin Mitomycin - adverse effects Mitomycin - therapeutic use Neurotoxicity Oncology Oxaliplatin Oxaliplatin - adverse effects Oxaliplatin - therapeutic use Patient Reported Outcome Measures Perfusion Peritoneal Neoplasms - secondary Peritoneal Neoplasms - therapy Peritoneal Surface Malignancy Peritoneum Prospective Studies Quality of Life Questionnaires Surgery Surgical Oncology Survival Survival Rate Well being Young Adult
ISSN:	1068-9265, 1534-4681, 1534-4681
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Abstract	Background This study evaluated health-related quality of life (HRQOL) using patient-reported outcomes in subjects with mucinous appendiceal neoplasms who underwent cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) as part of a randomized trial comparing mitomycin with oxaliplatin. Methods In this prospective multicenter study, 121 mucinous appendiceal cancer patients, with evidence of peritoneal dissemination who underwent CRS, were randomized to receive mitomycin (divided 40 mg) or oxaliplatin (200 mg/m 2 ) for HIPEC. The Functional Assessment of Cancer Therapy Neurotoxicity (FACT-G/NTX) questionnaire was utilized to assess HRQOL. The Trial Outcome Index (TOI) is a summary index responsive to changes in physical/functional outcomes. Repeated measures mixed models with an unstructured variance matrix were applied to assess changes in HRQOL longitudinally. Results Baseline questionnaire compliance was 95.9%. Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66–0.96; p = 0.017). The TOI was significantly lower in the mitomycin group compared with the oxaliplatin arm at 12 weeks ( p = 0.044; score difference 6.35) and 24 weeks after surgery ( p = 0.049; score difference 5.61). At 12 weeks after surgery, declines from baseline were significant in the TOI ( p = 0.004; score decline 8.99), PWB ( p < 0.001; score decline 2.83), and FWB ( p < 0.001; score decline 3.42) in the mitomycin group but not the oxaliplatin group. Conclusions Compared with mitomycin, HIPEC perfusion with oxaliplatin results in significantly better physical and functional outcomes. With similar survival outcomes and complication rates, oxaliplatin should be considered as the chemoperfusion agent of choice in mucinous appendiceal cancer patients undergoing CRS/HIPEC.
AbstractList	BackgroundThis study evaluated health-related quality of life (HRQOL) using patient-reported outcomes in subjects with mucinous appendiceal neoplasms who underwent cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) as part of a randomized trial comparing mitomycin with oxaliplatin.MethodsIn this prospective multicenter study, 121 mucinous appendiceal cancer patients, with evidence of peritoneal dissemination who underwent CRS, were randomized to receive mitomycin (divided 40 mg) or oxaliplatin (200 mg/m2) for HIPEC. The Functional Assessment of Cancer Therapy Neurotoxicity (FACT-G/NTX) questionnaire was utilized to assess HRQOL. The Trial Outcome Index (TOI) is a summary index responsive to changes in physical/functional outcomes. Repeated measures mixed models with an unstructured variance matrix were applied to assess changes in HRQOL longitudinally.ResultsBaseline questionnaire compliance was 95.9%. Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66–0.96; p = 0.017). The TOI was significantly lower in the mitomycin group compared with the oxaliplatin arm at 12 weeks (p = 0.044; score difference 6.35) and 24 weeks after surgery (p = 0.049; score difference 5.61). At 12 weeks after surgery, declines from baseline were significant in the TOI (p = 0.004; score decline 8.99), PWB (p < 0.001; score decline 2.83), and FWB (p < 0.001; score decline 3.42) in the mitomycin group but not the oxaliplatin group.ConclusionsCompared with mitomycin, HIPEC perfusion with oxaliplatin results in significantly better physical and functional outcomes. With similar survival outcomes and complication rates, oxaliplatin should be considered as the chemoperfusion agent of choice in mucinous appendiceal cancer patients undergoing CRS/HIPEC. This study evaluated health-related quality of life (HRQOL) using patient-reported outcomes in subjects with mucinous appendiceal neoplasms who underwent cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) as part of a randomized trial comparing mitomycin with oxaliplatin.BACKGROUNDThis study evaluated health-related quality of life (HRQOL) using patient-reported outcomes in subjects with mucinous appendiceal neoplasms who underwent cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) as part of a randomized trial comparing mitomycin with oxaliplatin.In this prospective multicenter study, 121 mucinous appendiceal cancer patients, with evidence of peritoneal dissemination who underwent CRS, were randomized to receive mitomycin (divided 40 mg) or oxaliplatin (200 mg/m2) for HIPEC. The Functional Assessment of Cancer Therapy Neurotoxicity (FACT-G/NTX) questionnaire was utilized to assess HRQOL. The Trial Outcome Index (TOI) is a summary index responsive to changes in physical/functional outcomes. Repeated measures mixed models with an unstructured variance matrix were applied to assess changes in HRQOL longitudinally.METHODSIn this prospective multicenter study, 121 mucinous appendiceal cancer patients, with evidence of peritoneal dissemination who underwent CRS, were randomized to receive mitomycin (divided 40 mg) or oxaliplatin (200 mg/m2) for HIPEC. The Functional Assessment of Cancer Therapy Neurotoxicity (FACT-G/NTX) questionnaire was utilized to assess HRQOL. The Trial Outcome Index (TOI) is a summary index responsive to changes in physical/functional outcomes. Repeated measures mixed models with an unstructured variance matrix were applied to assess changes in HRQOL longitudinally.Baseline questionnaire compliance was 95.9%. Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66-0.96; p = 0.017). The TOI was significantly lower in the mitomycin group compared with the oxaliplatin arm at 12 weeks (p = 0.044; score difference 6.35) and 24 weeks after surgery (p = 0.049; score difference 5.61). At 12 weeks after surgery, declines from baseline were significant in the TOI (p = 0.004; score decline 8.99), PWB (p < 0.001; score decline 2.83), and FWB (p < 0.001; score decline 3.42) in the mitomycin group but not the oxaliplatin group.RESULTSBaseline questionnaire compliance was 95.9%. Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66-0.96; p = 0.017). The TOI was significantly lower in the mitomycin group compared with the oxaliplatin arm at 12 weeks (p = 0.044; score difference 6.35) and 24 weeks after surgery (p = 0.049; score difference 5.61). At 12 weeks after surgery, declines from baseline were significant in the TOI (p = 0.004; score decline 8.99), PWB (p < 0.001; score decline 2.83), and FWB (p < 0.001; score decline 3.42) in the mitomycin group but not the oxaliplatin group.Compared with mitomycin, HIPEC perfusion with oxaliplatin results in significantly better physical and functional outcomes. With similar survival outcomes and complication rates, oxaliplatin should be considered as the chemoperfusion agent of choice in mucinous appendiceal cancer patients undergoing CRS/HIPEC.CONCLUSIONSCompared with mitomycin, HIPEC perfusion with oxaliplatin results in significantly better physical and functional outcomes. With similar survival outcomes and complication rates, oxaliplatin should be considered as the chemoperfusion agent of choice in mucinous appendiceal cancer patients undergoing CRS/HIPEC. This study evaluated health-related quality of life (HRQOL) using patient-reported outcomes in subjects with mucinous appendiceal neoplasms who underwent cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) as part of a randomized trial comparing mitomycin with oxaliplatin. In this prospective multicenter study, 121 mucinous appendiceal cancer patients, with evidence of peritoneal dissemination who underwent CRS, were randomized to receive mitomycin (divided 40 mg) or oxaliplatin (200 mg/m ) for HIPEC. The Functional Assessment of Cancer Therapy Neurotoxicity (FACT-G/NTX) questionnaire was utilized to assess HRQOL. The Trial Outcome Index (TOI) is a summary index responsive to changes in physical/functional outcomes. Repeated measures mixed models with an unstructured variance matrix were applied to assess changes in HRQOL longitudinally. Baseline questionnaire compliance was 95.9%. Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66-0.96; p = 0.017). The TOI was significantly lower in the mitomycin group compared with the oxaliplatin arm at 12 weeks (p = 0.044; score difference 6.35) and 24 weeks after surgery (p = 0.049; score difference 5.61). At 12 weeks after surgery, declines from baseline were significant in the TOI (p = 0.004; score decline 8.99), PWB (p < 0.001; score decline 2.83), and FWB (p < 0.001; score decline 3.42) in the mitomycin group but not the oxaliplatin group. Compared with mitomycin, HIPEC perfusion with oxaliplatin results in significantly better physical and functional outcomes. With similar survival outcomes and complication rates, oxaliplatin should be considered as the chemoperfusion agent of choice in mucinous appendiceal cancer patients undergoing CRS/HIPEC. Background This study evaluated health-related quality of life (HRQOL) using patient-reported outcomes in subjects with mucinous appendiceal neoplasms who underwent cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) as part of a randomized trial comparing mitomycin with oxaliplatin. Methods In this prospective multicenter study, 121 mucinous appendiceal cancer patients, with evidence of peritoneal dissemination who underwent CRS, were randomized to receive mitomycin (divided 40 mg) or oxaliplatin (200 mg/m 2 ) for HIPEC. The Functional Assessment of Cancer Therapy Neurotoxicity (FACT-G/NTX) questionnaire was utilized to assess HRQOL. The Trial Outcome Index (TOI) is a summary index responsive to changes in physical/functional outcomes. Repeated measures mixed models with an unstructured variance matrix were applied to assess changes in HRQOL longitudinally. Results Baseline questionnaire compliance was 95.9%. Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66–0.96; p = 0.017). The TOI was significantly lower in the mitomycin group compared with the oxaliplatin arm at 12 weeks ( p = 0.044; score difference 6.35) and 24 weeks after surgery ( p = 0.049; score difference 5.61). At 12 weeks after surgery, declines from baseline were significant in the TOI ( p = 0.004; score decline 8.99), PWB ( p < 0.001; score decline 2.83), and FWB ( p < 0.001; score decline 3.42) in the mitomycin group but not the oxaliplatin group. Conclusions Compared with mitomycin, HIPEC perfusion with oxaliplatin results in significantly better physical and functional outcomes. With similar survival outcomes and complication rates, oxaliplatin should be considered as the chemoperfusion agent of choice in mucinous appendiceal cancer patients undergoing CRS/HIPEC.
Author	Mansfield, Paul Shen, Perry McQuellon, Richard Bartlett, David L. Levine, Edward A. Moaven, Omeed Votanopoulos, Konstantinos I. Stewart, John H. Russell, Greg
AuthorAffiliation	3 Department of Surgical Oncology, MD Anderson Cancer Center, Houston, TX 5 Section of Surgical Oncology, Department of General Surgery, Wake Forest Baptist Health, Winston Salem, NC 2 Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA 4 Department of Surgery, University of Illinois, Chicago, IL 1 Department of Surgery, Wake Forest University, Winston Salem, NC
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Author_xml	– sequence: 1 givenname: Omeed surname: Moaven fullname: Moaven, Omeed organization: Department of Surgery, Wake Forest University – sequence: 2 givenname: Konstantinos I. surname: Votanopoulos fullname: Votanopoulos, Konstantinos I. organization: Department of Surgery, Wake Forest University – sequence: 3 givenname: Perry surname: Shen fullname: Shen, Perry organization: Department of Surgery, Wake Forest University – sequence: 4 givenname: Paul surname: Mansfield fullname: Mansfield, Paul organization: Department of Surgical Oncology, MD Anderson Cancer Center – sequence: 5 givenname: David L. surname: Bartlett fullname: Bartlett, David L. organization: Department of Surgery, University of Pittsburgh Medical Center – sequence: 6 givenname: Greg surname: Russell fullname: Russell, Greg organization: Department of Surgery, Wake Forest University – sequence: 7 givenname: Richard surname: McQuellon fullname: McQuellon, Richard organization: Department of Surgery, Wake Forest University – sequence: 8 givenname: John H. surname: Stewart fullname: Stewart, John H. organization: Department of Surgery, University of Illinois – sequence: 9 givenname: Edward A. surname: Levine fullname: Levine, Edward A. email: elevine@wakehealth.edu organization: Department of Surgery, Wake Forest University, Section of Surgical Oncology, Department of General Surgery, Wake Forest Baptist Health
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publication-title: Surg Oncol doi: 10.1016/j.suronc.2014.10.002 – reference: 31848812 - Ann Surg Oncol. 2020 Mar;27(3):630-631
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Snippet	Background This study evaluated health-related quality of life (HRQOL) using patient-reported outcomes in subjects with mucinous appendiceal neoplasms who... This study evaluated health-related quality of life (HRQOL) using patient-reported outcomes in subjects with mucinous appendiceal neoplasms who underwent... BackgroundThis study evaluated health-related quality of life (HRQOL) using patient-reported outcomes in subjects with mucinous appendiceal neoplasms who...
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SubjectTerms	Adenocarcinoma, Mucinous - secondary Adenocarcinoma, Mucinous - therapy Adult Aged Aged, 80 and over Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use Appendiceal Neoplasms - pathology Appendiceal Neoplasms - therapy Appendix Cancer Chemotherapy Combined Modality Therapy Cytoreduction Surgical Procedures Female Gastrointestinal cancer Health Status Humans Hyperthermia, Induced Male Medicine Medicine & Public Health Middle Aged Mitomycin Mitomycin - adverse effects Mitomycin - therapeutic use Neurotoxicity Oncology Oxaliplatin Oxaliplatin - adverse effects Oxaliplatin - therapeutic use Patient Reported Outcome Measures Perfusion Peritoneal Neoplasms - secondary Peritoneal Neoplasms - therapy Peritoneal Surface Malignancy Peritoneum Prospective Studies Quality of Life Questionnaires Surgery Surgical Oncology Survival Survival Rate Well being Young Adult
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Title	Health-Related Quality of Life After Cytoreductive Surgery/HIPEC for Mucinous Appendiceal Cancer: Results of a Multicenter Randomized Trial Comparing Oxaliplatin and Mitomycin
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