title: The effects of palliative chemotherapy in metastatic colorectal cancer patients with an ECOG performance status of 3 and 4.
abstract: BACKGROUND
  Although chemotherapy is standard for patients with mCRC and ECOG PS of 0/1, the real benefit for patients with ECOG PS > 2 remains uncertain, because they are generally excluded from clinical trials. Our objectives were to compare the survival and safety of ECOG PS 3/4 patients who were administered chemotherapy with those who received BSC only.
  
  
  METHODS
  We retrospectively analyzed all consecutive mCRC patients who started first-line chemotherapy at our institution in a 4-year period. A multivariable Cox regression model was used to adjust for prognostic factors and logistic regression, to identify predictive factors of Grade 3/4 toxicity.
  
  
  RESULTS
  From June 2008 to June 2012, 240 consecutive patients were included: 100 (41.7%) had an ECOG PS of 0/1, 75 (31.3%) ECOG PS of 2, and 65 (27%) ECOG PS of 3/4. Median survival for patients treated with chemotherapy was 18.4 months for patients with ECOG PS of 0/1, 10.8 months for those with ECOG PS of 2, and 6.8 months for patients with ECOG PS of 3/4. Among those with ECOG PS of 3/4, chemotherapy use led to a nonsignificant survival gain (median, 6.8 vs. 2.3 months for BSC; P = .13). Factors significantly associated with worse survival in an adjusted analysis were right-sided tumors (hazard ratio [HR], 2.97; P = .005) and ECOG PS status (ECOG PS 2 vs. 0/1; HR, 1.67; P = .025, and ECOG PS 3/4 vs. 0/1; HR, 2.67; P < .0001). The rate of Grade ≥ 3 toxicities during the first cycle did not differ significantly across ECOG groups; likely because 40% of ECOG PS 3/4 patients received upfront dose-reduced therapy. The rates of treatment-related hospitalization were similar across all ECOG groups. All deaths were disease-associated.
  
  
  CONCLUSIONS
  Our retrospective study suggests that chemotherapy might benefit selected mCRC patients with poor PS. With up-front dose reduction and close monitoring for toxicity, the risk of serious adverse events is minimized.
authors.affiliation: Disciplina de Radiologia e Oncologia, Faculdade de Medicina da Universidade de São Paulo, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil; Centro de Oncologia, Hospital Sírio Libanes, São Paulo, Brazil. Electronic address: marcela.teixeira@icesp.org.br.
authors.forename: Marcela
authors.initials: M
authors.lastname: Crosara Teixeira
authors.affiliation: Disciplina de Radiologia e Oncologia, Faculdade de Medicina da Universidade de São Paulo, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil; Centro de Oncologia, Hospital Sírio Libanes, São Paulo, Brazil.
authors.forename: Daniel Fernandes
authors.initials: DF
authors.lastname: Marques
authors.affiliation: Disciplina de Radiologia e Oncologia, Faculdade de Medicina da Universidade de São Paulo, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil; Centro de Oncologia, Hospital Sírio Libanes, São Paulo, Brazil.
authors.forename: Anezka Celis
authors.initials: AC
authors.lastname: Ferrari
authors.affiliation: Disciplina de Radiologia e Oncologia, Faculdade de Medicina da Universidade de São Paulo, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil.
authors.forename: Michel Fabiano Silva
authors.initials: MF
authors.lastname: Alves
authors.affiliation: Disciplina de Radiologia e Oncologia, Faculdade de Medicina da Universidade de São Paulo, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil.
authors.forename: Alexandra Khichfy
authors.initials: AK
authors.lastname: Alex
authors.affiliation: Disciplina de Radiologia e Oncologia, Faculdade de Medicina da Universidade de São Paulo, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil; Centro de Oncologia, Hospital Sírio Libanes, São Paulo, Brazil.
authors.forename: Jorge
authors.initials: J
authors.lastname: Sabbaga
authors.affiliation: Disciplina de Radiologia e Oncologia, Faculdade de Medicina da Universidade de São Paulo, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil; Centro de Oncologia, Hospital Sírio Libanes, São Paulo, Brazil.
authors.forename: Paulo M
authors.initials: PM
authors.lastname: Hoff
authors.affiliation: Disciplina de Radiologia e Oncologia, Faculdade de Medicina da Universidade de São Paulo, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil.
authors.forename: Rachel P
authors.initials: RP
authors.lastname: Riechelmann
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010166:Palliative Care / Q000379:methods*; D011379:Prognosis; D012189:Retrospective Studies; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents
keywords: Best supportive care; Chemotherapy; Colorectal cancer; Palliative Care; Poor performance status