Evidence map›Paper›PMID 27724870›Full record

Trial reportBMC cancer2016

SAKK 24/09: safety and tolerability of bevacizumab plus paclitaxel vs. bevacizumab plus metronomic cyclophosphamide and capecitabine as first-line therapy in patients with HER2-negative advanced stage breast cancer - a multicenter, randomized phase III trial.

Christoph Rochlitz, Martin Bigler, Roger von Moos, Jürg Bernhard, Klazien Matter-Walstra, Andreas Wicki, Khalil Zaman, Sandro Anchisi, Marc Küng, Kyung-Jae Na and 12 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01131195 (Safety and Tolerability of Bevacizumab Plus Paclitaxel vs. Bevacizumab Plus Metronomic Cyclophosphamide and Capecitabine as First-Line Therapy in Patients With HER2-Negative Metastatic or Locally Recurrent Breast Cancer - A Multicenter, Randomized Phase III Trial.), which is not on this map. Cited by 24 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 5 pooled it
3.3field-weighted citation impact, top 6% 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.

NCT01131195 phase3completednot on this map

Safety and Tolerability of Bevacizumab Plus Paclitaxel vs. Bevacizumab Plus Metronomic Cyclophosphamide and Capecitabine as First-Line Therapy in Patients With HER2-Negative Metastatic or Locally Recurrent Breast Cancer - A Multicenter, Randomized Phase III Trial.

TypeinterventionalSponsorSwiss Cancer InstituteRan2010 to 2018Enrolled139ConditionsBreast CancerArmsbevacizumab, Paclitaxel, Bevacizumab, Cyclophosphamide, Capecitabine
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 5 syntheses or guidelines pooled it, 46 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

22 authors at 13 institutions in 2 countries.

Christoph RochlitzDepartment of Oncology, University Hospital Basel, Petersgraben 4, Basel, CH-4031, Switzerland. Christoph.Rochlitz@usb.ch.ORCID 0000-0001-7808-2497
Martin BiglerSAKK Coordinating Center, Bern, Switzerland.
Roger von MoosDepartment of Oncology, Kantonsspital Graubünden, Chur, Switzerland.
Jürg BernhardInternational Breast Cancer Study (IBCSG) and Inselspital, Bern University Hospital, Bern, Switzerland.
Klazien Matter-WalstraSAKK Coordinating Center, Bern, Switzerland and European Center for Pharmaceutical Medicine, University Basel, Basel, Switzerland.
Andreas WickiDepartment of Oncology, University Hospital Basel, Petersgraben 4, Basel, CH-4031, Switzerland.
Khalil ZamanDepartment of Oncology, University Hospital Lausanne, Lausanne, Switzerland.
Sandro AnchisiDepartment of Oncology, Hospital of Valais, Sion, Switzerland.
Marc KüngDepartment of Oncology, Kantonsspital Fribourg, Fribourg, Switzerland.
Kyung-Jae NaSAKK Coordinating Center, Bern, Switzerland.
Daniela BärtschiSAKK Coordinating Center, Bern, Switzerland.
Markus BornerDepartment of Oncology, Spitalzentrum Biel, Biel, Switzerland.
Tamara RordorfDepartment of Oncology, University Hospital Zürich, Zürich, Switzerland.
Daniel RauchDepartment of Oncology, Spital STS, Thun, Switzerland.
Andreas MüllerDepartment of Oncology, Kantonsspital Winterthur, Winterthur, Switzerland.
Thomas RuhstallerDepartment of Oncology, Kantonsspital St. Gallen, St. Gallen, Switzerland.
Marcus VetterDepartment of Oncology, University Hospital Basel, Petersgraben 4, Basel, CH-4031, Switzerland.
Andreas TrojanDepartment of Oncology, OnkoZentrum Zürich, Zürich, Switzerland.
Ursula Hasler-StrubDepartment of Oncology, Kantonsspital St. Gallen, St. Gallen, Switzerland.
Richard CathomasDepartment of Oncology, Kantonsspital Graubünden, Chur, Switzerland.
Ralph WinterhalderLuzerner Kantonsspital, Luzerne, Switzerland.
Swiss Group for Clinical Cancer Research (SAKK)
University Hospital of Basel · CHKantonsspital Graubünden · CHKantonsspital St. Gallen · CHSwiss Group For Clinical Cancer Research · CHHFR Freiburg Kantonsspital · CHHôpital du Valais · CHKantonsspital Winterthur · CHLuzerner Kantonsspital · CHNovartis (Switzerland) · CHSpital STS · CHSpitalzentrum Centre hospitalier Biel- Bienne · CHUniversity Hospital of Bern · CHUniversity Hospital of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdding bevacizumab to chemotherapy improves response rates and progression-free survival (PFS) in metastatic breast cancer (mBC). We aimed to demonstrate decreased toxicity with metronomic chemotherapy/bevacizumab compared with paclitaxel/bevacizumab.

methodsThis multicenter, randomized phase III trial compared bevacizumab with either paclitaxel (arm A) or daily oral capecitabine-cyclophosphamide (arm B) as first-line treatment in patients with HER2-negative advanced breast cancer. The primary endpoint was the incidence of selected grade 3-5 adverse events (AE) including: febrile neutropenia, infection, sensory/motor neuropathy, and mucositis. Secondary endpoints included objective response rate, disease control rate, PFS, overall survival (OS), quality of life (QoL), and pharmacoeconomics. The study was registered prospectively with ClinicalTrials.gov, number NCT01131195 on May 25, 2010.

resultsBetween September 2010 and December 2012, 147 patients were included at 22 centers. The incidence of primary endpoint-defining AEs was similar in arm A (25 % [18/71]; 95 % CI 15-35 %) and arm B (24 % [16/68]; 95 % CI 13-34 %; P = 0.96). Objective response rates were 58 % (42/73; 95 % CI 0.46-0.69) and 50 % (37/74; 95 % CI 0.39-0.61) in arms A and B, respectively (P = 0.45). Median PFS was 10.3 months (95 % CI 8.7-11.3) in arm A and 8.5 months (95 % CI 6.5-11.9) in arm B (P = 0.90). Other secondary efficacy endpoints were not significantly different between study arms. The only statistically significant differences in QoL were less hair loss and less numbness in arm B. Treatment costs between the two arms were equivalent.

conclusionThis trial failed to meet its primary endpoint of a reduced rate of prespecified grade 3-5 AEs with metronomic bevacizumab, cyclophosphamide and capecitabine.

Indexed as

Administration, MetronomicAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiomarkers, TumorBreast NeoplasmsCapecitabineCyclophosphamideErb-b2 Receptor Tyrosine KinasesFemaleHumansMaleMiddle AgedNeoplasm MetastasisBevacizumabBiomarkers, TumorCapecitabineCyclophosphamideErb-b2 Receptor Tyrosine KinasesPaclitaxelBevacizumabBreast cancerMetronomic chemotherapyToxicity

Identifiers

PMID27724870
PMCPMC5057418
OpenAlexW2531871678

What OpenQuestion holds

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Registered trials

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.