Evidence map›Paper›PMID 26497654›Full record

Trial reportBMC cancer2015

Capecitabine and oxaliplatin combined with bevacizumab are feasible for treating selected Japanese patients at least 75 years of age with metastatic colorectal cancer.

Yoshinori Munemoto, Mitsuro Kanda, Keiichiro Ishibashi, Taishi Hata, Michiya Kobayashi, Junichi Hasegawa, Mutsumi Fukunaga, Akinori Takagane, Toshio Otsuji, Yasuhiro Miyake and 5 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.9field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 18 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 14 institutions in 1 country.

Yoshinori MunemotoDepartment of Surgery, Fukuiken Saiseikai Hospital, Fukui, Japan. Y-MUNEMOTO@fukui.saiseikai.or.jp.
Mitsuro KandaDepartment of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan. m-kanda@med.nagoya-u.ac.jp.
Keiichiro IshibashiDepartment of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan. k_ishi@saitama-med.ac.jp.
Taishi HataDepartment of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan. thata@gesurg.med.osaka-u.ac.jp.
Michiya KobayashiDepartment of Human Health and Medical Sciences, Kochi Medical School, Kohasu, Japan. kobayasm@kochi-u.ac.jp.
Junichi HasegawaDepartment of Surgery, Osaka Rosai Hospital, Sakai, Japan. j-hasegawa@orh.go.jp.
Mutsumi FukunagaDepartment of Surgery, Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, Japan. fukunaga1404@hp.pref.hyogo.jp.
Akinori TakaganeSurgical Division, Hakodate Goryoukaku Hospital, Hakodate, Japan. takagane@gobyou.com.
Toshio OtsujiDepartment of Internal Medicine, Dongo Hospital, Yamatotakada, Nara, Japan. hxgcd792@yahoo.co.jp.
Yasuhiro MiyakeDepartment of Surgery, Minoh City Hospital Gastrointestinal Research Center, Minoh, Osaka, Japan. hotymiyake@hotmail.com.
Michitaka NagaseDepartment of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan. mnagase@nagoya-1st.jrc.or.jp.
Junichi SakamotoDirector, Tokai Central Hospital, Gifu, Japan. sakamjun@med.nagoya-u.ac.jp.
Masaki MatsuokaMatsuoka Clinic, Kitakatsuragi, Nara, Japan. masa2722@mac.com.
Koji ObaDepartment of Biostatistics, School of Public Health, Tokyo University Graduate School of Medicine, Tokyo, Japan. oba@epistat.m.u-tokyo.ac.jp.
Hideyuki MishimaUnit of Cancer Center, Aichi Medical University, Nagakute, Japan. hmishima@aichi-med-u.ac.jp.
Aichi Medical University · JPFukui-ken Saiseikai Hospital · JPGifu University · JPHakodate National Hospital · JPHyogo Prefectural Nishinomiya Hospital · JPKochi Medical School Hospital · JPMinoh City Hospital · JPNagoya University · JPNara City Hospital · JPOsaka Rosai Hospital · JPOsaka University · JPSocial Insurance Saitama Chuo Hospital · JPThe University of Tokyo · JPTokai Central Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough number of elderly patients with metastatic colorectal cancer (mCRC) is rapidly increasing, this population is often underrepresented in clinical trials. Recently, a phase II trial demonstrated that capecitabine and oxaliplatin (XELOX) combined with bevacizumab XELOX plus bevacizumab was effective and well tolerated by elderly patients with mCRC who reside in Western countries. The aim of this study was to evaluate the safety and efficacy of XELOX plus bevacizumab for Japanese patients aged ≥ 75 years with mCRC.

methodsThis prospective, open-label phase II trial recruited patients aged ≥ 75 years with previously untreated mCRC between March 2010 and January 2012. Treatment consisted of 7.5 mg/kg of intravenous bevacizumab and 130 mg/m(2) of oxaliplatin on day 1 of each cycle combined with 2000 mg/m(2) of oral capecitabine per day on days 1-14 of each cycle. Treatment was repeated every 3 weeks until disease progression or termination of the study. The primary endpoint was progression-free survival; the secondary endpoints were toxicity, overall response rate, time-to-treatment failure, and overall survival.

resultsThirty-six patients (male 58%; median age 78 years; colon cancer 67%) met all eligibility criteria and received at least one course of the planned treatment. The median time-to-treatment failure was 7.0 months. Twelve patients (33.3%) experienced adverse effects (AEs) ≥ grade 3 and frequent AEs ≥ grade 3, including neutropenia (22.2%) and neuropathy (13.9%). Hypertension was the most frequent AE ≥ grade 3 associated with bevacizumab (11.1%). Low baseline creatinine clearance associated significantly with the incidence of AEs ≥ grade 3. Response and disease control rates were 55.6 and 91.7%, respectively. Median progression-free and overall survival times were 11.7 months (95% confidence interval, 8.0-13.4 months) and 22.9 months, respectively.

conclusionXELOX combined with bevacizumab was well tolerated by selected Japanese patients aged ≥ 75 years with mCRC patients, and controlled clinical trials are now required to determine the survival benefit.

Indexed as

Asian PeopleAgedAged, 80 and overAge FactorsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCapecitabineColorectal NeoplasmsFemaleHumansMaleNauseaNeutropeniaOrganoplatinum CompoundsOxaliplatinProspective StudiesBevacizumabCapecitabineOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID26497654
PMCPMC4619505
OpenAlexW1859421745

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.