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Adjuvant Chemotherapy vs Observation for Patients With Adverse Pathologic Features at Radical Cystectomy Previously Treated With Neoadjuvant Chemotherapy.

Abstract Despite existing evidence of a benefit associated with cisplatin-based adjuvant chemotherapy (AC) after radical cystectomy (RC) for chemotherapy-naive patients with pT3/T4 and/or pN+ urothelial carcinoma of the bladder (UCB), to our knowledge, no studies have addressed the effectiveness of AC in those who received neoadjuvant chemotherapy (NAC) before surgery.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title jama oncology
Publication Year Start




PMID- 28837718
OWN - NLM
STAT- Publisher
DA  - 20170824
LR  - 20170824
IS  - 2374-2445 (Electronic)
IS  - 2374-2437 (Linking)
DP  - 2017 Aug 24
TI  - Adjuvant Chemotherapy vs Observation for Patients With Adverse Pathologic
      Features at Radical Cystectomy Previously Treated With Neoadjuvant Chemotherapy.
LID - 10.1001/jamaoncol.2017.2374 [doi]
AB  - Importance: Despite existing evidence of a benefit associated with
      cisplatin-based adjuvant chemotherapy (AC) after radical cystectomy (RC) for
      chemotherapy-naive patients with pT3/T4 and/or pN+ urothelial carcinoma of the
      bladder (UCB), to our knowledge, no studies have addressed the effectiveness of
      AC in those who received neoadjuvant chemotherapy (NAC) before surgery.
      Objective: To assess the comparative effectiveness of AC vs observation for
      patients with pT3/T4 and/or pN+ UCB previously treated with NAC and RC. Design,
      Setting, and Participants: This observational cohort study used the National
      Cancer Data Base (January 1, 2006, through December 31, 2012) to identify
      individuals who received NAC and RC followed by AC or observation for pT3/T4
      and/or pN+ UCB. Main Outcomes and Measures: After multiple imputation was used to
      handle missing data, inverse probability of treatment weighting (IPTW)-adjusted
      Kaplan-Meier and Cox proportional hazards regression analyses were performed with
      a 6-month conditional landmark to compare overall survival (OS) among patients
      who received NAC and RC followed by AC vs observation. In addition, exploratory
      analyses were conducted to examine the heterogeneity of the treatment effect
      according to age (continuous), sex (female vs male), Charlson comorbidity index
      (>/=1 vs 0), pT/N stage (pT3/T4N0 vs pTanyN+), and surgical margin status
      (positive vs negative) by testing interaction terms within the IPTW-adjusted Cox 
      proportional hazards regression model. Results: Of the 788 patients with pT3/T4
      and/or pN+ UCB (mean [SD] age, 65.3 [9.4] years; 603 [76.5%] male and 185 [23.5%]
      female), 184 (23.4%) received NAC and RC followed by AC and 604 (76.6%) received 
      NAC and RC followed by observation. The 6-month conditional landmark,
      IPTW-adjusted Kaplan-Meier curves showed that median OS was significantly longer 
      for NAC and RC followed by AC (29.9 months; interquartile range, 15.1-85.4
      months) vs NAC and RC followed by observation (24.2 months; interquartile range, 
      12.9-58.9 months) (P = .046). The 5-year IPTW-adjusted rates of OS were 36.8% for
      NAC and RC followed by AC vs 24.7% for NAC and RC followed by observation. In the
      IPTW-adjusted Cox proportional hazards regression analysis, NAC and RC followed
      by AC was associated with a significant OS benefit (hazard ratio, 0.78; 95% CI,
      0.61-0.99; P = .046). Interaction term analyses indicated that the OS benefit of 
      NAC and RC followed by AC decreased significantly with age (hazard ratio, 0.97;
      95% CI, 0.95-0.99; P = .02), whereas no significant interaction was observed with
      sex (P = .82), Charlson comorbidity index (P = .51), pT/N stage (P = .95), and
      surgical margin status (P = .29). Conclusions and Relevance: This study found
      that AC after NAC and RC may be associated with an OS benefit for patients with
      pT3/T4 and/or pN+ UCB. The present findings should be considered as preliminary
      evidence to conduct a randomized clinical trial to address this association.
FAU - Seisen, Thomas
AU  - Seisen T
AD  - Center for Surgery and Public Health, Division of Urological Surgery, Brigham and
      Women's Hospital, Harvard Medical School, Boston, Massachusetts.
FAU - Jamzadeh, Asha
AU  - Jamzadeh A
AD  - Center for Outcomes Research, Analytics, and Evaluation, Vattikuti Urology
      Institute, Henry Ford Health System, Detroit, Michigan.
FAU - Leow, Jeffrey J
AU  - Leow JJ
AD  - Center for Surgery and Public Health, Division of Urological Surgery, Brigham and
      Women's Hospital, Harvard Medical School, Boston, Massachusetts.
FAU - Roupret, Morgan
AU  - Roupret M
AD  - Department of Urology, Pitie Salpetriere Hospital, Assistance Publique des
      Hopitaux de Paris, Pierre and Marie Curie University, Paris, France.
FAU - Cole, Alexander P
AU  - Cole AP
AD  - Center for Surgery and Public Health, Division of Urological Surgery, Brigham and
      Women's Hospital, Harvard Medical School, Boston, Massachusetts.
FAU - Lipsitz, Stuart R
AU  - Lipsitz SR
AD  - Center for Surgery and Public Health, Division of Urological Surgery, Brigham and
      Women's Hospital, Harvard Medical School, Boston, Massachusetts.
FAU - Kibel, Adam S
AU  - Kibel AS
AD  - Center for Surgery and Public Health, Division of Urological Surgery, Brigham and
      Women's Hospital, Harvard Medical School, Boston, Massachusetts.
FAU - Nguyen, Paul L
AU  - Nguyen PL
AD  - Department of Radiation Oncology, Brigham and Women's Hospital, Harvard Medical
      School, Boston, Massachusetts.
FAU - Sun, Maxine
AU  - Sun M
AD  - Center for Surgery and Public Health, Division of Urological Surgery, Brigham and
      Women's Hospital, Harvard Medical School, Boston, Massachusetts.
FAU - Menon, Mani
AU  - Menon M
AD  - Center for Outcomes Research, Analytics, and Evaluation, Vattikuti Urology
      Institute, Henry Ford Health System, Detroit, Michigan.
FAU - Bellmunt, Joaquim
AU  - Bellmunt J
AD  - Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical
      School, Boston, Massachusetts.
FAU - Choueiri, Toni K
AU  - Choueiri TK
AD  - Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical
      School, Boston, Massachusetts.
FAU - Trinh, Quoc-Dien
AU  - Trinh QD
AD  - Center for Surgery and Public Health, Division of Urological Surgery, Brigham and
      Women's Hospital, Harvard Medical School, Boston, Massachusetts.
LA  - eng
PT  - Journal Article
DEP - 20170824
PL  - United States
TA  - JAMA Oncol
JT  - JAMA oncology
JID - 101652861
EDAT- 2017/08/25 06:00
MHDA- 2017/08/25 06:00
CRDT- 2017/08/25 06:00
AID - 2649754 [pii]
AID - 10.1001/jamaoncol.2017.2374 [doi]
PST - aheadofprint
SO  - JAMA Oncol. 2017 Aug 24. doi: 10.1001/jamaoncol.2017.2374.