Abstract 3568
Background
In CORRECT, REG significantly improved overall survival and PFS vs placebo in pts with treatment-refractory mCRC. We did a retrospective, exploratory subgroup analysis of REG-treated pts in CORRECT with PFS >4 m (long PFS) and ≤4 m (short PFS).
Methods
Pts with pretreated mCRC were randomized 2:1 to REG 160 mg or placebo QD for 3 weeks on/1 week off until disease progression, death, or unacceptable toxicity. PFS was the time from randomization to progression or death. Of 505 pts randomized to REG, 98 (19%) had long PFS and 407 (81%) had short PFS.
Results
Compared to short PFS pts, the long PFS group had a higher proportion of patients with ECOG PS0, 1–2 tumor sites, and ≥18 m since diagnosis of metastatic disease (Table). Long PFS pts received a median of 6 (1–12) cycles, short PFS pts a median of 2 (1–11). Mean actual daily doses were 138.7 mg (long PFS) and 149.2 mg (short PFS). Dose modifications occurred in 91% (long PFS) and 72% (short PFS). NCI-CTCAE (v3) grade (Gr) ≥3 REG-related treatment-emergent adverse events (TEAE) occurred in 64% (long PFS) and 53% (short PFS). Most common REG-related Gr ≥3 TEAEs included (long PFS, short PFS) hand–foot skin reaction (20%, 16%), hypertension (17%, 5%), fatigue (13%, 9%), diarrhea (16%, 5%), rash/desquamation (3%, 6%), and hypophosphatemia (5%, 3%). Gr ≥3 laboratory toxicities (long PFS, short PFS) included increased bilirubin (8%, 13%), ALT (6%, 5%), and AST (5%, 6%). Although REG-related TEAEs led to a higher dose modification rate in long PFS pts (71% vs 52% for short PFS), discontinuations due to REG-related TEAEs were similar (long PFS 5%; short PFS 9%).
| Long PFS (n = 98) | Short PFS (n = 407) | |
|---|---|---|
| Median age, yrs (range) | 61 (34–82) | 61 (22–82) |
| Male, % | 64 | 61 |
| Median body mass index, kg/m2 | 25.6 | 24.7 |
| ECOG PS, % 0 1 | 63 37 | 50 50 |
| No. of tumor sites, % 1 2 3 ≥4 | 30 38 16 16 | 17 35 30 18 |
| KRAS status, % mutant wildtype | 47 44 | 56 40 |
| Primary site of disease, % Colon Rectum Both | 52 37 10 | 67 28 5 |
| No. of prior regimens on or after diagnosis of metastatic disease, % 0–2 3 ≥4 | 22 22 55 | 28 25 47 |
Time since first diagnosis of metastatic disease to randomization, % ConclusionsThis exploratory analysis showed that pts with mCRC treated with REG who had PFS >4 m tended to have a better performance status, fewer metastatic tumor sites, and a longer time since diagnosis of metastatic disease, compared to pts with short PFS. Clinical trial identificationNCT01103323 Legal entity responsible for the studyBayer FundingBayer DisclosureA. Grothey: Advisory board: Bayer. Corporate-sponsored research: Bayer. A. Falcone: Advisory board: Amgen, Roche, Bayer, Lilly, Sanofi, Servier, Merck. Corporate-sponsored research: Roche, Amgen, Bayer, Merck, Sanofi. O. Bouche: Advisory board: Merck Serono, Roche. L. Mineur: Advisory board participation. A. Adenis: Corporate-sponsored research: Bayer, Sanofi Other substantive relationship: Bayer, Sanofi, Pfizer, Roche. J. Tabernero: Advisory board: Amgen, Bayer, Boehringer Ingelheim, Celgene, Chugai, Lilly, MSD, Merck Serono, Novartis, Roche, Sanofi, Symphogen, Takeda, Taiho. T. Yoshino: Corporate-sponsored research: GlaxoSmithKline K.K. Boehringer Ingelheim GmbH H-J. Lenz: Advisory board: Bayer. Lectures: Bayer. Clinical trial support: Bayer. R.M. Goldberg: Corporate-sponsored research: Bayer. L. Huang: Stock ownership: Bayer Other substantive relationships: Bayer (employee). A. Wagner: Other substantive relationships: Bayer (employee). E. Van Cutsem: Corporate-sponsored research: Bayer. All other authors have declared no conflicts of interest. Resources from the same sessionZUMA-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 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 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 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 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 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 What is the optimal annual interpretive volume for a radiologist reading screening mammograms?Presenter: Asli Uluturk Session: Poster display Resources: Abstract What decides breast conservation versus mastectomy in the background of diverse sociocultural environment, an Indian studyPresenter: Poonamalle Padmanabhan Bapsy Session: Poster display Resources: Abstract Waiting time to diagnosis and treatment of the head and neck cancer in four institutions in PortugalPresenter: Ana Castro Session: Poster display Resources: Abstract 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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