Maintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group

Simkens, Lieke H.J.; Tinteren, Harm van; May, Anne M.; Tije, Albert J. ten; Creemers, Geert-Jan; Loosveld, Olaf; Jongh, Felix E. de; Erdkamp, Frans; Erjavec, Z.; Torren, A.M.E. van der; Tol, Jolien; Braun, Hans J.; Nieboer, Peter; Hoeven, J.J.M. van der; Haasjes, Janny G.; Jansen, R. L. H.; Wals, J.; Cats, Annemieke; Derleyn, Veerle A.; Honkoop, AH; Mol, L.; Punt, Cornelis J.A.; Koopman, Miriam

doi:10.1016/s0140-6736(14)62004-3

Cited by 445 publications

(407 citation statements)

References 30 publications

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“…The Dutch Colorectal Cancer Group CAIRO3 study12 is a randomized phase 3 study that investigated the effect of maintenance treatment with low dose capecitabine + bevacizumab (CAP‐B) vs. observation in previously untreated mCRC patients not progressing during first‐line systemic treatment with 6 cycles of treatment with capecitabine + oxaliplatin + bevacizumab (CAPOX‐B, further defined as initial treatment) ( Figure 1). Main eligibility criteria for randomization were histological proof of CRC, unresectable metastatic disease, and World Health Organization performance status 0–1.…”

Section: Methodsmentioning

confidence: 99%

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Impact of different palliative systemic treatments on skeletal muscle mass in metastatic colorectal cancer patients

Kurk

Peeters

Dorresteijn

et al. 2018

J cachexia sarcopenia muscle

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BackgroundObservational studies suggest that loss of skeletal muscle mass (SMM) is associated with chemotherapy‐related toxicity, poor quality of life, and poor survival in metastatic colorectal cancer (mCRC) patients. Little is known about the evolution of SMM during palliative systemic therapy. We investigated changes in SMM during various consecutive palliative systemic treatment regimens using repeated abdominal computed tomography scans of mCRC patients who participated in the randomized phase 3 CAIRO3 study.MethodsIn the CAIRO3 study, mCRC patients with stable disease or better after 6 cycles of first‐line treatment with capecitabine + oxaliplatin + bevacizumab (CAPOX‐B) were randomized between maintenance treatment with capecitabine + bevacizumab (CAP‐B) or observation. Upon first disease progression, in both groups, CAPOX‐B or other treatment was reintroduced until the second disease progression, which was the primary study endpoint. We analysed 1355 computed tomography scans of 450 (81%) CAIRO3 patients (64 ± 9.0 years, CAP‐B n = 223; observation n = 227) for SMM at four time points (i.e. prior to the start of pre‐randomization initial treatment, at randomization, and at first and at second disease progression) using the Slice‐o‐matic software and single slice evaluation at the lumbar 3 level. By using accepted and widely used formulas, whole body SMM was calculated. A linear mixed effects model, adjusted for relevant confounders, was used to assess SMM changes for the total group and within and between study arms.ResultsDuring 6 cycles of initial treatment with CAPOX‐B prior to randomization, SMM decreased significantly in all patients [CAP‐B arm: −0.53 kg (95% CI −1.12; −0.07) and observation arm: −0.85 kg (−1.45; −0.25)]. After randomization, SMM recovered during CAP‐B treatment by 1.32 kg (0.73; 1.90) and observation by 1.20 kg (0.63; 1.78) (median time from randomization to first disease progression 8.6 and 4.1 months for CAP‐B arm and observation arm, respectively). After first progression and during reintroduction treatment with CAPOX‐B or other treatment, SMM again decreased significantly and comparable in both arms, CAP‐B: −2.71 kg (−3.37; −2.03), and observation: −2.01 kg (−2.64; −1.41) (median time from first progression until second progression CAP‐B arm: 4.7 months and observation arm: 6.6 months).ConclusionsThis longitudinal study provides a unique insight in SMM changes in mCRC patients during palliative systemic treatment regimens, including observation. Our data show that muscle loss is reversible and may be influenced by the intensity of systemic regimens. Although studies have shown prognostic capacity for SMM, the effects of subsequent changes in SMM are unknown and may be clues for new future therapeutic interventions.

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Section: Methodsmentioning

confidence: 99%

“…We used the data of patients from the randomized phase 3 CAIRO3 study12 in which patients were evaluated by CT scans at regular time points during subsequent palliative systemic treatment regimens, including observation.…”

Section: Introductionmentioning

confidence: 99%

Impact of different palliative systemic treatments on skeletal muscle mass in metastatic colorectal cancer patients

Kurk

Peeters

Dorresteijn

et al. 2018

J cachexia sarcopenia muscle

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“…Basierend auf den Daten der AIO KRK-0207-Studie sowie der CAIRO3-Studie ermöglicht die Erhaltungstherapie im Vergleich zur Therapiepause eine prolongierte progressionsfreie Zeit, hat aber keinen Einfluss auf das Gesamtüberleben [1148,1153].…”

Section: Erhaltungstherapie Vs Therapiepauseunclassified

S3-Leitlinie – Kolorektales Karzinom

Schmiegel

Buchberger

Follmann³

et al. 2017

Z Gastroenterol

148

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“…The use of postoperative 5‐fluorouracil‐based chemotherapy has become standard treatment in high‐risk Stage II and Stage III colon cancer patients 11, 12. For metastatic CRC, the use of combination chemotherapy, various new systemic and regional multimodality treatments, metastasectomies and other local treatments, such as hyperthermic intraperitoneal chemotherapy, are increasingly being performed 13, 14, 15…”

Section: Introductionmentioning

confidence: 99%

An overview of 25 years of incidence, treatment and outcome of colorectal cancer patients

Brouwer

Bos

Lemmens

et al. 2018

Intl Journal of Cancer

236

193

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Regarding the continuous changes in the diagnostic process and treatment of colorectal cancer (CRC), it is important to evaluate long‐term trends which are relevant in giving direction for further research and innovations in cancer patient care. The aim of this study was to analyze developments in incidence, treatment and survival for patients diagnosed with CRC in the Netherlands. For this population‐based retrospective cohort study, all patients diagnosed with CRC between 1989 and 2014 in the Netherlands were identified using data of the nationwide population‐based Netherlands Cancer Registry (n = 267,765), with follow‐up until January 1, 2016. Analyses were performed for trends in incidence, mortality, stage distribution, treatment and relative survival measured from the time of diagnosis. The incidence of both colon and rectal cancer has risen. The use of postoperative chemotherapy for Stage III colon cancer increased (14–60%), as well as the use of preoperative (chemo)radiotherapy for rectal cancer (2–66%). The administration of systemic therapy and metastasectomy increased for Stage IV disease patients. The 5‐year relative survival increased significantly from 53 to 62% for colon cancer and from 51 to 65% for rectal cancer. Ongoing advancements in treatment, and also improvement in other factors in the care of CRC patients—such as diagnostics, dedicated surgery and pre‐ and postoperative care—lead to a continuous improvement in the relative survival of CRC patients. The increasing incidence of CRC favors the implementation of the screening program, of which the effects should be monitored closely.

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Maintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group

Cited by 445 publications

References 30 publications

Impact of different palliative systemic treatments on skeletal muscle mass in metastatic colorectal cancer patients

Impact of different palliative systemic treatments on skeletal muscle mass in metastatic colorectal cancer patients

S3-Leitlinie – Kolorektales Karzinom

An overview of 25 years of incidence, treatment and outcome of colorectal cancer patients

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