Abstract 2383
Background
In the phase 3 randomized CORRECT trial, REG improved survival vs placebo in treatment-refractory mCRC; 19% of REG-treated patients had PFS >4 m. In the single-arm phase 3b CONSIGN trial (NCT01538680) of REG, adverse events (AEs) and PFS were consistent with phase 3 trials in mCRC. We performed a retrospective analysis of CONSIGN patients with PFS >4 m (long PFS) and ≤4 m (short PFS).
Methods
Patients with treatment-refractory mCRC received REG 160 mg QD for 3 wks on/1 wk off until disease progression, death, or unacceptable toxicity. Treatment beyond progression was at the investigator's discretion. PFS (investigator assessed) was the time from treatment assignment to progression or death. Of 2872 patients assigned to REG, 674 (23%) had long PFS and 2198 (77%) had short PFS. Descriptive statistics are reported.
Results
Compared to the short PFS group, the long PFS group had a higher proportion of patients with ECOG PS 0, with no liver metastases, and ≥18 m since diagnosis of metastatic disease (Table). Long PFS patients received a median of 7 cycles (2–29); 75% ≥6 cycles; 34% ≥9 cycles. Short PFS patients received a median of 2 cycles (1–33). Dose reductions due to AEs (long PFS, short PFS) were 65%, 40%; actual mean daily doses were 136 mg, 149 mg, respectively. The most common drug-related NCI-CTCAE v4 grade ≥3 AEs (long PFS, short PFS) were hypertension (20%, 14%), hand–foot skin reaction (19%, 12%), fatigue (13%, 13%), diarrhea (8%, 4%), and hypophosphatemia (8%, 4%).
Long PFS (n = 674) | Short PFS (n = 2198) | |
---|---|---|
Median age, yrs (range) | 62 (27–86) | 62 (19–89) |
Age, % ≥70 yrs ≥75 yrs | 19 8 | 23 10 |
ECOG PS, % 0 1 | 58 41 | 44 56 |
Liver metastases, % No Yes | 32 67 | 20 80 |
KRAS status, % mutant wild-type | 47 49 | 52 43 |
Primary site of disease, % Colon Rectum Both | 66 28 6 | 64 28 8 |
No. of prior regimens on or after diagnosis of metastatic disease, % 0–2 3 ≥4 | 22 28 50 | 28 27 45 |
Time since first diagnosis of metastatic disease to treatment assignment, % ConclusionsThis exploratory analysis suggests that among patients with mCRC treated with regorafenib, the long PFS (>4 months) subgroup tended to have a higher proportion of patients with better performance status, with no liver involvement, and a longer time since diagnosis of metastatic disease. Higher rates of some AEs and dose reductions in the long PFS group may be related to longer treatment duration. Clinical trial identificationNCT01538680 Legal entity responsible for the studyBayer FundingBayer DisclosureR. Garcia-Carbonero: Advisory board: Roche, Amgen, Merck, Sanofi, Lilly, Boehringer Ingelheim, Bayer, Novartis, Ipsen. E. Van Cutsem: Corporate-sponsored research: Bayer. F. Ciardiello: Advisory board: Bayer, Roche, Merck Serono, Lilly, Sanofi, AstraZeneca. Corporate-sponsored research: AstraZeneca, Merck Serono, Roche, Bayer. M. Ychou: Advisory board: Bayer, Roche, Merck. J-F. Seitz: Advisory board: Roche, Sanofi-Aventis. R.D. Hofheinz: Corporate-sponsored research: Amgen, Medac, Merck, Roche, Sanofi. U. Verma: Advisory board: Bayer. Speakers bureau: Intramed. A. Grothey: Advisory board: Bayer Corporate-sponsored research: Bayer (institute). A. Miriyala, J. Kalmus, C. Kappeler: Stock ownership: Bayer. Other substantive relationships: Bayer (employee). A. Falcone: Advisory board: Amgen, Roche, Bayer, Lilly, Sanofi, Servier, Merck. Corporate-sponsored research: Roche, Amgen, Bayer, Merck, Sanofi. All other authors have declared no conflicts of interest. Resources from the same session3713 - ZUMA-3: A phase 1/2 multi-center study evaluation the safety and efficacy of KTE-C19 anti-CD19 CAR T cells in adult patients with relapsed/refractory B precursor acute lymphoblastic leukemia (R/R ALL)Presenter: Bijal Shah Session: Poster display Resources: Abstract 3305 - ZUMA-2: A phase 2 multi-center study evaluating the efficacy of KTE-C19 (Anti-CD19 CAR T cells) in patients with relapsed/refractory Mantle cell lymphoma (R/R MCL)Presenter: Michael Wang Session: Poster Display Resources: Abstract 3222 - ZUMA-1: A phase 2 multi-center study evaluating anti-CD19 chimeric antigen receptor (CAR) T cells in patients with refractory aggressive non-Hodgkin lymphoma (NHL)Presenter: Sattva Neelapu Session: Poster Display Resources: Abstract 1560 - Younger age as a prognostic indicator in breast cancer: Correlation between clinical-pathologic factors and miRNAs and long-term follow-upPresenter: Maria Teresa Martinez Session: Poster display Resources: Abstract 2335 - Window study of the PARP inhibitor rucaparib in patients with primary triple negative or BRCA1/2 related breast cancer (RIO)Presenter: Christy Toms Session: Poster display Resources: Abstract 3291 - Whole exome sequencing (WES) and RNA sequencing (RNA-seq) in routine clinical practice for colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) patients (pts)Presenter: Géraldine Perkins Session: Poster display Resources: Abstract 3607 - What is the optimal annual interpretive volume for a radiologist reading screening mammograms?Presenter: Asli Uluturk Session: Poster display Resources: Abstract 1963 - What decides breast conservation versus mastectomy in the background of diverse sociocultural environment, an Indian studyPresenter: Poonamalle Padmanabhan Bapsy Session: Poster display Resources: Abstract 3503 - Waiting time to diagnosis and treatment of the head and neck cancer in four institutions in PortugalPresenter: Ana Castro Session: Poster display Resources: Abstract 1997 - Wait times for diagnosis and treatment of lung cancer: a single centre experiencePresenter: Catherine Labbe Session: Poster Display Resources: Abstract This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. For more detailed information on the cookies we use, please check our Privacy Policy.
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