Evidence map›Paper›PMID 28333021›Full record

Trial reportInternational journal of radiation oncology, biology, physics2017

A Phase 1/2 Trial of a Combination of Paclitaxel and Trastuzumab With Daily Irradiation or Paclitaxel Alone With Daily Irradiation After Transurethral Surgery for Noncystectomy Candidates With Muscle-Invasive Bladder Cancer (Trial NRG Oncology RTOG 0524).

M Dror Michaelson, Chen Hu, Huong T Pham, Douglas M Dahl, Chin Lee-Wu, Gregory P Swanson, Jacqueline Vuky, R Jeffrey Lee, Luis Souhami, Brian Chang and 3 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIControlled Clinical Trial
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

23 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Recent Advances and Future Directions in Bladder Preservation Therapy for Muscle-Invasive Bladder Cancer.International journal of urology : official journal of the Japanese Urological Association · 2025
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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

13 authors.

M Dror MichaelsonMassachusetts General Hospital Cancer Center, Boston, Massachusetts. Electronic address: dmichaelson1@partners.org.
Chen HuNRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania; Sydney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Huong T PhamVirginia Mason CCOP, Seattle, Washington.
Douglas M DahlMassachusetts General Hospital Cancer Center, Boston, Massachusetts.
Chin Lee-WuMassachusetts General Hospital Cancer Center, Boston, Massachusetts.
Gregory P SwansonUniversity of Texas at San Antonio, San Antonio, Texas.
Jacqueline VukyVirginia Mason CCOP, Seattle, Washington.
R Jeffrey LeeIntermountain Medical Center, Murray, Utah.
Luis SouhamiMcGill University, Montréal, Quebec.
Brian ChangParkview Cancer Center, Parkview Hospital, Fort Wayne, Indiana.
Asha GeorgeNRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
Howard SandlerCedars-Sinai Medical Center, Los Angeles, California.
William ShipleyMassachusetts General Hospital Cancer Center, Boston, Massachusetts.

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
RTOG Foreign AccrualU10CA021661 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI CURRAN, WALTER J. · 1985 to 2013
$150.3M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Mei-Yin C Polley · 2014 to 2026
$146.4M
RTOG Foreign AccrualsU10CA037422 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI BRUNER, DEBORAH WATKINS · 1985 to 2013
$30.4M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareU10CA180867 · NCI · DANA-FARBER CANCER INST · PI BURSTEIN, HAROLD JOHN, KIBEL, ADAM S · 2014 to 2018
$6.2M
NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA037422NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180867NCI NIH HHS U10 CA180868
6 · The paper itself

Abstract

purposeBladder preservation therapy is an effective treatment for muscle-invasive urothelial carcinoma (UC). In this study we treated noncystectomy candidates with daily radiation and weekly paclitaxel for 7 weeks. Patients whose tumors showed her2/neu overexpression were additionally treated with weekly trastuzumab. METHODS AND MATERIALS: Sixty-eight evaluable patients were treated with radiation therapy and either paclitaxel + trastuzumab (group 1) or paclitaxel alone (group 2). Groups were assigned on the basis of her2/neu immunohistochemistry results. Patients received 1.8-Gy fractions to a total dose of 64.8 Gy. The primary endpoint of the study was treatment-related toxicity, and secondary endpoints included complete response (CR) rate, protocol completion rate, and survival.

resultsA total of 20 evaluable patients were treated in group 1 and 46 patients in group 2. Acute treatment-related adverse events (AEs) were observed in 7 of 20 patients in group 1 (35%) and 14 of 46 patients in group 2 (30.4%). Protocol therapy was completed by 60% (group 1) and 74% (group 2) of patients. Most incompletions were due to toxicity, and the majority of AEs were gastrointestinal, including 1 grade 5 AE (group 1). Two other deaths (both in group 2) were unrelated to protocol therapy. No unexpected cardiac, hematologic, or other toxicities were observed. The CR rate at 1 year was 72% for group 1 and 68% for group 2.

conclusionsIn patients with muscle-invasive UC who are not candidates for cystectomy, daily radiation combined with paclitaxel is an effective treatment strategy with a high completion rate and moderate toxicity. In patients with her2/neu-positive tumors, a group generally considered to have worse outcomes, the addition of trastuzumab appears to result in comparable efficacy and toxicity. Further biomarker-driven trials should be undertaken in advancing treatment of this challenging disease.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapy, AdjuvantCystectomyFemaleGastrointestinal DiseasesHumansMaleMiddle AgedMuscle, SmoothNeoplasm InvasivenessPaclitaxelRadiation InjuriesTrastuzumabTreatment OutcomePaclitaxelTrastuzumab

Identifiers

PMID28333021
PMCPMC5536836

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.