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A randomized study ...
A randomized study of KRAS-guided maintenance therapy with bevacizumab, erlotinib or metronomic capecitabine after first-line induction treatment of metastatic colorectal cancer : the Nordic ACT2 trial
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- Hagman, H. (author)
- Cty Hosp Ryhov, Dept Oncol, S-55185 Jonkoping, Sweden.,County Hospital Ryhov, Sweden
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- Frodin, J. -E (author)
- Karolinska Institutet
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- Berglund, Åke (author)
- Uppsala universitet,Experimentell och klinisk onkologi,University of Uppsala Hospital, Sweden
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- Sundberg, J. (author)
- Skane Univ Hosp, Dept Oncol, Lund, Sweden.,Skåne University Hospital, Sweden
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- Vestermark, L. W. (author)
- Odense Univ Hosp, Dept Oncol, DK-5000 Odense, Denmark.,Odense University Hospital, Denmark
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- Albertsson, Maria (author)
- Linköpings universitet,Avdelningen för kliniska vetenskaper,Hälsouniversitetet,Region Östergötland, Onkologiska kliniken US,Linkoping Univ Hosp, Dept Oncol, S-58185 Linkoping, Sweden.
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- Fernebro, E. (author)
- Vaxjo Hosp, Dept Oncol, Vaxjo, Sweden.,Vaxjo Hospital, Sweden
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- Johnsson, A. (author)
- Skane Univ Hosp, Dept Oncol, Lund, Sweden.,Skåne University Hospital, Sweden
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Cty Hosp Ryhov, Dept Oncol, S-55185 Jonkoping, Sweden County Hospital Ryhov, Sweden (creator_code:org_t)
- Elsevier BV, 2016
- 2016
- English.
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In: Annals of Oncology. - : Elsevier BV. - 0923-7534 .- 1569-8041. ; 27:1, s. 140-147
- Related links:
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https://doi.org/10.1...
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https://urn.kb.se/re...
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Abstract
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- Maintenance treatment (mt) with bevacizumab (bev) +/- erlotinib (erlo) has modest effect after induction chemotherapy in metastatic colorectal cancer (mCRC). We hypothesized the efficacy of erlo to be dependent on KRAS mutational status and investigated this by exploring mt strategies with bev +/- erlo and low-dose capecitabine (cap). Included patients had mCRC scheduled for first-line therapy, Eastern Cooperative Oncology Group (ECOG) 0-1 and no major comorbidities. Treatment with XELOX/FOLFOX or XELIRI/FOLFIRI + bev was given for 18 weeks. After induction, patients without progression were eligible for randomization to mt; KRAS wild-type (wt) patients were randomized to bev +/- erlo (arms wt-BE, N = 36 versus wt-B, N = 35), KRAS mutated (mut) patients were randomized to bev or metronomic cap (arms mut-B, N = 34 versus mut-C, N = 33). Primary end point was progression-free survival (PFS) rate (PFSr) at 3 months after start of mt. A pooled analysis of KRAS wt patients from the previous ACT study was performed. We included 233 patients. Median age was 64 years, 62% male, 68% ECOG 0, 52% with primary tumor in situ. A total of 138 patients started mt after randomization. PFSr was 64.7% versus 63.6% in wt-B versus wt-BE, P = 1.000; and 75% versus 66.7% in mut-B versus mut-C, P = 0.579, with no significant difference in median PFS and overall survival (OS). In the pooled cohort, median PFS was 3.7 months in wt-B (N = 64) and 5.7 months in wt-BE (N = 62) (hazard ratios 1.03, 95% confidence interval 0.70-1.50, P = 0.867). The frequency of any grade 3/4 toxicities during mt was: 28%/58%/18%/15% (wt-B/wt-BE/mut-B/mut-C). Addition of erlo to bev as mt in KRAS wt mCRC did not significantly improve PFS or OS, but it did increase toxicity. KRAS status does not seem to influence the outcome of treatment with erlotinib. Metronomic cap warrants further investigation in mt strategies, given our explorative results. NCT01229813.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
Keyword
- metastatic colorectal cancer
- maintenance treatment
- bevacizumab
- erlotinib
- capecitabine
- metronomic chemotherapy
Publication and Content Type
- ref (subject category)
- art (subject category)
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