2131 Efficacy and safety of nab-paclitaxel (nab-P) in patients (pts) with previously treated metastatic colorectal cancer (mCRC): The phase II COLO-001 trial

S376 Conflict of interest: Ownership: YZ, KSO and GD are Amgen stockholders (and employees). Advisory Board: MK has acted on Advisory boards for Amgen. RH has acted on Advisory boards for Amgen, Roche, Merck Serono, Lilly, Pfizer, Sanofi Aventis, Ipsen, and Bayer Healthcare. LM has acted on Advisory boards for Amgen. Board of Directors: None. Corporatesponsored Research: RH has received research funding from Amgen, Roche, Merck Serono and Bayer Healthcare. RG has received research support from Amgen (not in the context of this trial). JT has received research funding from Amgen. Other Substantive Relationships: RH has received travel grants from Roche, Merck Serono, Lilly, Pfizer, Sanofi Aventis, Ipsen and Bayer Healthcare. RG has received honoraria from Amgen (not in the context of this trial). JT has received honoraria from Amgen. CHK has received honoraria from Amgen and Merck. 2131 POSTER Efficacy and safety of nab-paclitaxel (nab-P) in patients (pts) with previously treated metastatic colorectal cancer (mCRC): The phase II COLO-001 trial M. Ducreux1 , J. Bennouna2 , A. Adenis3 , T. Conroy4 , A. Lievre5 , F. Portales6 , D. McGovern7 , L. Li7 , A. Romano7 . 1 Institut Gustave Roussy, Head of GI Unit and Executive Medical Director, Villejuif, France; 2 Institut ´ de Cancerologie de L’ouest, Department of Medical Oncology, Nantes, France; 3 Centre Oscar Lambret, Gastrointestinal Oncology Department, 4 ´ Nord, France; Institut de Cancerologie de Lorraine, Chief executive ` ˆ officer, Vandoeuvre-les-Nancy Cedex, France; 5 Institut Curie − Hopital Rene´ Huguenin, Department of Medical Oncology, Paris, France; 6 Institut du Cancer de Montpellier, Oncology Department, Montepellier, France; 7 Celgene Corporation, Oncology, Summit, USA Background: CRC is the 3rd leading cause of cancer death worldwide. The 5-yr overall survival (OS) rate is 13% for pts with distant metastases. Options are limited for pts in whom standard therapies have failed. In metastatic pancreatic cancer, a disease in which taxanes have demonstrated limited efficacy, nab-P + gemcitabine (Gem) demonstrated significantly longer OS than Gem alone (median, 8.7 vs 6.6 months; HR 0.72; P < 0.001). Based on favorable pharmacokinetic properties and antitumor activity in early clinical data, nab-P was tested in refractory mCRC. Methods: In this single arm, open-label, multicenter phase II study, pts with previously treated mCRC (both RAS wild-type [cohort 1] and RASmutated [cohort 2]) were treated with nab-P 125 mg/m2 on days 1, 8, and 15 of each 28-day cycle (qw 3/4). Pts were eligible if they had confirmed measurable disease, with a known KRAS mutation status, ECOG PS of 0 or 1, and had progressive disease 2 months since last standard therapy. Treatment continued until disease progression, unacceptable toxicity, or withdrawal of consent. The primary objective was progression-free survival (PFS) at 8 wks; secondary objectives included OS, overall response rate, disease control rate (DCR), duration of response, and safety. All pts were evaluated for tumor response every 8 wks. The study planned to enroll up to 86 pts in 2 stages using Simon’s optimal 2-stage design. In stage 1, 15 pts/cohort would be accrued; an additional 28 pts/cohort would be enrolled in stage 2 if 9/15 pts were progression-free at wk 8; otherwise the study would be stopped at the end of stage 1. Results: Forty-one pts were enrolled (18 in cohort 1, 23 in cohort 2) from 5 centers in France. Baseline characteristics were similar in the 2 cohorts: 58% had ECOG PS 1, 83% had colon and 18% had rectal cancer. The median number of prior lines of therapy received was 4 (range 2−16). 72% of pts in cohort 1 and 50% in cohort 2 were male. At the 8-wk assessment, 67% and 80% of pts had disease progression or died; median PFS was 8.1 (95% CI, 7.71–8.57) and 7.9 (95% CI, 7.57–8.00) wks in cohorts 1 and 2, respectively. No pt achieved a complete or partial response. DCRs were 18% and 15% in cohorts 1 and 2. 39% and 22% of pts in cohorts 1 and 2 had at least 1 dose reduction. No new safety signals were identified. The most common grade 3 AEs in cohorts 1 and 2 were neutropenia (17% and 26%), asthenia (22% and 22%), general physical health deterioration (0 and 17%), and peripheral neuropathy (22% and 9%). Conclusions: Per the stopping rule, enrollment was halted after stage 1. nab-P 125 mg/m2 qw 3/4 was well-tolerated in pts with heavily previously treated metastatic CRC, and AEs were consistent with the known safety profile. Regardless of RAS mutation status, nab-P monotherapy didn’t demonstrate promising antitumor activity in this pt population. Conflict of interest: Corporate-sponsored Research: A. Lievre − Merck Serono. M.Ducreux − Roche, Chugai, Pfizer. Other Substantive Relationships: D. McGovern − Celgene employee, stock ownership. L. Li − Celgene employee, stock ownership. A. Romano − Celgene employee, stock ownership. A. Lievre − Merck Serono, Roche, Amgen, Sanofi, Lilly. J. Bennouna − Roche, Boehringer-Ingelheim, Astra-Zeneca. M. Ducreux − Roche, Celgene, Merck Serono, Amgen, Novartis, Sanofi, Pfizer.

Abstracts 2132 POSTER Retrospective observational study to estimate the attrition of patients across lines of systemic treatment for metastatic colorectal cancer in Canada H. Kennecke1 , J. Maroun2 , P. Kavan3 , N. Aucoin4 , S. Berry5 , F. Couture6 , M. Poulin-Costello7 , B. Gillesby7 . 1 British Columbia Cancer Agency, Medical Oncology, Vancouver, Canada; 2 University of Ottawa, Medical Oncology, Ottawa, Canada; 3 McGill University, Department of Oncology, ˆ Montreal, Canada; 4 Hopital Cite´ de la Sante´ de Laval, Oncology, Laval, Canada; 5 Sunnybrook Health Sciences Centre, Medical Oncology and Hematology, Toronto, Canada; 6 Centre Hospitalier Universitaire ´ de Quebec and Faculty of Medicine, Laval University, Quebec, Canada; 7 Amgen Canada, Inc, Mississauga, Canada Background: Selection and sequencing of treatment regimens for individual metastatic colorectal cancer (mCRC) patients is governed by the goals of maintaining reasonable quality of life while extending survival; treatment patterns have not yet been described for these patients in the Canadian healthcare system. The goals of this study were to describe therapy patterns and their timing along with KRAS status among patients with mCRC. Methods: A retrospective medical chart review included patients diagnosed with mCRC from January 1, 2009 onwards, who started 1st -line systemic treatment for mCRC from January 1 to December 31, 2009. A line of therapy was defined as a change in regimen or break in treatment >120 days. The primary endpoint was whether or not a patient received 2nd , 3rd , or higher lines of systemic therapy for mCRC. Treatment was analyzed using a multiplicative intensity model, adjusting for death as a competing risk. Secondary endpoints included type of systemic agent and KRAS status. Results: 200 patients were included from 6 centres in Canada. The median age was 62 yr; 78% had stage 4 CRC at diagnosis. The proportions of patients who started 1st and subsequent lines of systemic therapy and the duration of each line are shown in the table. 103 (52%) patients underwent KRAS testing. 38 (56%) of 68 patients with wt KRAS tumours received epidermal growth factor receptor inhibitor (EGFRi) therapy; 14 (21%) died and 4 were lost to follow-up within 6 months of testing. The median number of days between lines of treatment was 28, 52, and 70 for the 1st and 2nd , 2nd and 3rd , and 3rd and 4th lines. Chemotherapy + bevacizumab was the most frequent 1st -line regimen; EGFRi or chemotherapy as monotherapy were more common for 2nd and later lines. Line of therapy

% of patients a Overall

Median duration, wks (Q1, Q3)

Type of regimen C+B

C alone

Overall B alone

1st 2nd

100

69 (62, 75)

26 (20, 32)

0 (0, 2)

27 (15, 46)

70 (63, 76)

26 (20, 32)

42 (35, 48)

1 (0, 4)

16 (10, 26)

3rd 4th

30 (24, 37)

12 (8, 17)

11 (7, 16)

7 (4, 11)

16 (9, 33)

15 (10, 20)

2 (1, 5)

6 (3, 9)

7 (4, 11)

14 (9, 24)

B, biologic therapy; C, chemotherapy.TNL> a Percentages relative to all patients who started 1st -line therapy; radiotherapy is not shown.

Conclusion: Although systemic treatment is common for mCRC patients, a progressive decline in the proportion of patients receiving subsequent therapy was observed, with 70%, 30%, and 15% receiving 2nd , 3rd , and 4th -line therapies. Writing support funded by Amgen. Conflict of interest: Advisory Board: H.K. for Hoffman la Roche and Sanofi Ltd. J.M. for Amgen, Inc. S.B. for Amgen, Inc, Sanofi, Ltd, and Hoffman la Roche Ltd. N.A. for Amgen, Inc. Corporate-sponsored Research: J.M. and N.A. from Amgen. Other Substantive Relationships: B.G. and M.P.-C. are employees of Amgen Canada, Inc. 2134 POSTER ¨ Comparative analysis of the Kohne, GERCOR and GEMCAD prognostic models in metastatic colorectal cancer (mCRC) patients treated with first-line bevacizumab-based combination chemotherapy ˜ 1, G. Bruixola1 , R. Diaz-Beveridge1 , M. Melian1 , J. Caballero1 , O. Nino 1 C. Esco´ın1 , D. Akhoundova1 , C. Salvador1 , A. Segura1 , A. Gimenez ´ , ´ J. Aparicio1 . 1 Hospital Universitario y Politecnico La Fe, Medical Oncology, Valencia, Spain Background: The Kohne ¨ risk classification was developed originally in mCRC patients (pts) treated with 5-FU-based schemes, while the GERCOR group developed afterwards a model for pts treated with oxaliplatin or irinotecan-based 1st-line chemotherapy. The GEMCAD group has designed an index that also accounts for resectable liver-only metastasis. Little information is known about the validity of these systems in pts treated with antiangiogenics in the 1st-line setting. Methods: Retrospective review of FOLFOX/FOLFIRI-Bev treated pts (2006–2014) at our centre. Progression-free survival (PFS) and overall survival (OS) were assessed. Univariate and multivariate analysis of