Evidence map›Paper›PMID 28549414›Full record

Trial reportBMC cancer2017

Phase I/II study of induction chemotherapy using carboplatin plus irinotecan and sequential thoracic radiotherapy (TRT) for elderly patients with limited-disease small-cell lung cancer (LD-SCLC): TORG 0604.

Yuki Misumi, Hiroaki Okamoto, Jiichiro Sasaki, Noriyuki Masuda, Mari Ishii, Tsuneo Shimokawa, Yukio Hosomi, Yusuke Okuma, Makoto Nagamata, Takashi Ogura and 10 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.4field-weighted citation impact, top 37% 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

7 citing papers in PubMed, 10 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

20 authors at 7 institutions in 1 country.

Yuki MisumiDepartment of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa, Japan. yu02-misumi@city.yokohama.jp.
Hiroaki OkamotoDepartment of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa, Japan.
Jiichiro SasakiDepartment of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1 Minami-ku, Sagamihara, Kanagawa, Japan.
Noriyuki MasudaDepartment of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1 Minami-ku, Sagamihara, Kanagawa, Japan.
Mari IshiiDepartment of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa, Japan.
Tsuneo ShimokawaDepartment of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa, Japan.
Yukio HosomiDepartment of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, Japan.
Yusuke OkumaDepartment of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, Japan.
Makoto NagamataDepartment of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, Japan.
Takashi OguraDepartment of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, 6-16-1 Tomiokahigashi, Kanazawa-ku, Yokohama, Kanagawa, Japan.
Terufumi KatoDepartment of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, 6-16-1 Tomiokahigashi, Kanazawa-ku, Yokohama, Kanagawa, Japan.
Masafumi SataDepartment of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, 6-16-1 Tomiokahigashi, Kanazawa-ku, Yokohama, Kanagawa, Japan.
Sakiko OtaniDepartment of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1 Minami-ku, Sagamihara, Kanagawa, Japan.
Akira TakakuraDepartment of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1 Minami-ku, Sagamihara, Kanagawa, Japan.
Koichi MinatoDepartment of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1 Takahayashinishi-cho, Ohta, Gunma, Japan.
Yosuke MiuraDepartment of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1 Takahayashinishi-cho, Ohta, Gunma, Japan.
Takuma YokoyamaDepartment of Respiratory Medicine, Kyorin University School of Medicine, Kyorin University Hospital, 6-20-2 Shinkawa, Mitaka, Tokyo, Japan.
Saori TakataDepartment of Respiratory Medicine, Kyorin University School of Medicine, Kyorin University Hospital, 6-20-2 Shinkawa, Mitaka, Tokyo, Japan.
Katsuhiko NaokiDivision of Pulmonary Medicine, Keio University School of Medicine, Keio University Hospital, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan.
Koshiro WatanabeDepartment of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa, Japan.
Yokohama Municipal Citizen's Hospital · JPKitasato University · JPKanagawa Cardiovascular and Respiratory Center · JPTokyo Metropolitan Komagome Hospital · JPGunma Children's Medical Center · JPKyorin University Hospital · JPKeio University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe role of irinotecan for elderly patients with LD-SCLC has been unclear, and the timing of TRT combined with chemotherapy has not been fully evaluated.

methodsPatients aged > 70 years with untreated, measurable, LD-SCLC, performance status (PS) 0-2, and adequate organ function were eligible. Treatment consisted of induction with carboplatin on day 1 and irinotecan on days 1 and 8, every 21 days for 4 cycles, and sequential TRT (54Gy in 27 fractions). Carboplatin doses were based on AUC of 4 and 5 (levels 1 and 2, respectively), with a fixed irinotecan dose (50 mg/m

resultsForty-three patients were enrolled and forty-one were finally analyzed (median age: 75 years [range 70-86 years); males 31; PS 0/1/2, n = 22/18/1]. Two patients were excluded because of protocol violation (ascertained to be extensive disease). Twelve patients were accrued at phase I and the number of patients with carboplatin dose-limiting toxicities at levels-1 (n = 6) and -2 (n = 6) were 1(grade 3 hypertension) and 2 (grade 4 thrombocytopenia), respectively. The phase II trial was expanded to 29 additional patients receiving the level 1 carboplatin dose, total of 35 patients. The median number of chemotherapy cycles was 4 (range 1-4), and the median radiation dose was 54Gy (range 36-60). Toxicities were generally mild. There were 4 complete and 27 partial responses (response rate 88.6%). With a median follow-up of 52 months, the median progression-free and overall survival times of phase II were 11.2 and 27.1 months, respectively.

conclusionsInduction chemotherapy of carboplatin plus irinotecan and sequential TRT was well tolerated and effective for elderly patients with LD-SCLC. Additional confirmatory studies are warranted.

trial registrationTrial registration number: UMIN000007352 Name of registry: UMIN. Date of registration: 1/Dec/2006. Date of enrolment of the first participant to the trial: 6/Feb/2007. Clinical trial registration date: 1/Feb/2006 (prospective).

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCarboplatinChemoradiotherapyDisease-Free SurvivalFemaleHumansInduction ChemotherapyIrinotecanKaplan-Meier EstimateLung NeoplasmsMaleSmall Cell Lung CarcinomaCamptothecinCarboplatinIrinotecanCarboplatinElderlyIrinotecanLD-SCLCPhase IPhase IISequential radiotherapy

Identifiers

PMID28549414
PMCPMC5446686
OpenAlexW2617047226

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.