title: Efficacy and safety of nab-paclitaxel in patients with previously treated metastatic colorectal cancer: a phase II COLO-001 trial.
abstract: OBJECTIVE
  This single-arm, phase II trial evaluated nab-paclitaxel monotherapy in pretreated patients with metastatic colorectal cancer (mCRC).
  
  
  METHODS
  Patients with mCRC (RAS wild-type and RAS mutant cohorts) received nab-paclitaxel 125 mg/m2days 1, 8, and 15 (28-day cycle). The primary endpoint was investigator-assessed progression-free survival (PFS) rate at week 8; secondary endpoints included overall survival, overall response rate, and safety. Stage 1 planned enrollment was 15 patients per cohort per Simon 2-stage design. Stage 2 enrollment was to continue unless ≤8 of the first 15 patients per cohort achieved PFS at 8 weeks.
  
  
  RESULTS
  Stage 1 enrolled 41 patients (RAS wild type: n = 18; RAS mutant: n = 23). In both RAS cohorts, 3 of 15 patients initially enrolled were progression-free at week 8 (20%; 95% CI 4.0-48.0). Median PFS was 8.1 weeks (95% CI 7.7-8.6) and 7.9 weeks (95% CI 7.6-8.0) for RAS wild-type and RAS mutant cohorts, respectively. There were no complete or partial responses. The overall disease control rate was 16% (95% CI 6.0-32.0), and rates were similar in the RAS wild-type and RAS mutant cohorts (18 and 15%, respectively). No new safety signals were reported; the most common grade ≥3 adverse events included neutropenia, asthenia, and peripheral neuropathy. This study did not progress to stage 2 per the preplanned statistical stopping rule.
  
  
  CONCLUSIONS
  In patients with heavily pretreated mCRC, nab-paclitaxel did not demonstrate promising antitumor activity; further assessment of nab-paclitaxel monotherapy in this population of patients is not supported.
  
  
  BACKGROUND
  NCT02103062.
authors.affiliation: Gustave Roussy, Cancer Campus Grand Paris, Villejuif, France. Michel.DUCREUX@gustaveroussy.fr.|Université Paris-Saclay, Saclay, France. Michel.DUCREUX@gustaveroussy.fr.
authors.forename: Michel
authors.initials: M
authors.lastname: Ducreux
authors.affiliation: Institut de Cancérologie de l'Ouest, Site Hospitalier Nord, Saint-Herblain, France.
authors.forename: Jaafar
authors.initials: J
authors.lastname: Bennouna
authors.affiliation: Centre Oscar Lambret, Lille, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: Adenis
authors.affiliation: Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Conroy
authors.affiliation: Institut Curie, Hôpital René Huguenin, Saint Cloud, France.|CHU Pontchaillou, Rennes, France.
authors.forename: Astrid
authors.initials: A
authors.lastname: Lièvre
authors.affiliation: Institut du Cancer de Montpellier, Montpellier, France.
authors.forename: Fabienne
authors.initials: F
authors.lastname: Portales
authors.affiliation: Celgene Corporation, 86 Morris Avenue, Summit, NJ, USA.
authors.forename: Julie
authors.initials: J
authors.lastname: Jeanes
authors.affiliation: Celgene Corporation, 86 Morris Avenue, Summit, NJ, USA.
authors.forename: Li
authors.initials: L
authors.lastname: Li
authors.affiliation: Celgene International Sàrl, Boudry, Switzerland.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Romano
mesh_terms: D000418:Albumins / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology; D005260:Female; D011905:Genes, ras; D006801:Humans; D008297:Male; D008875:Middle Aged; D009154:Mutation; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D017239:Paclitaxel
keywords: Colorectal cancer; Metastatic; Previously treated; Refractory; nab-Paclitaxel