Evidence map›Paper›PMID 32918848›Full record

Trial reportThe oncologist2021

Phase II Study of Panitumumab Monotherapy in Chemotherapy-Naïve Frail or Elderly Patients with Unresectable RAS Wild-Type Colorectal Cancer: OGSG 1602.

Tetsuji Terazawa, Takeshi Kato, Masahiro Goto, Katsuya Ohta, Shingo Noura, Hironaga Satake, Yoshinori Kagawa, Hisato Kawakami, Hiroko Hasegawa, Kazuhiro Yanagihara and 10 more

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

Trial report in The oncologist, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 23% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Article
  8. Elderly Rectal Cancer: An Updated Review.Current oncology reports · 2024
    Review
  9. Article
  10. Article
  11. Review
  12. Targeted Therapies in Older Adults With Solid Tumors.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
    Review
  13. Article
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 16 institutions in 1 country.

Tetsuji TerazawaCancer Chemotherapy Center, Osaka Medical College, Takatsuki City, Osaka, Japan.ORCID 0000-0002-5722-8730
Takeshi KatoDepartment of Gastroenterological Surgery, National Hospital Organization Osaka National Hospital, Chuo-ku, Osaka, Japan.
Masahiro GotoCancer Chemotherapy Center, Osaka Medical College, Takatsuki City, Osaka, Japan.
Katsuya OhtaDepartment of Gastroenterological surgery, Higashiosaka City Medical Center, Higashiosaka City, Osaka, Japan.
Shingo NouraDepartment of Surgery, Osaka Rosai Hospital, Kita-Ku, Sakai City, Osaka, Japan.
Hironaga SatakeDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Minatojima minamimachi, chuo-ku, Kobe City, Hyogo, Japan.
Yoshinori KagawaDepartment of Surgery, Kansai Rosai Hospital, Inabaso, Amagasaki City, Hyogo, Japan.
Hisato KawakamiDepartment of Medical Oncology, Kindai University Faculty of Medicine, Oonohigasi, Osakasayama-shi, Osaka, Japan.
Hiroko HasegawaDepartment of Gastroenterology and Hepatology, National Hospital Organization Osaka National Hospital, Hoenzaka, Chuo-ku, Osaka, Japan.
Kazuhiro YanagiharaDepartment of Medical Oncology, Kansai Electric Power Hospital, Fukushima, Fukushima-ku, Osaka, Japan.
Tatsushi ShingaiDepartment of Surgery, Saiseikai Senri Hospital, Suita City, Osaka, Japan.
Ken NakataDepartment of Surgery, Sakai City Medical Center, Ebaraji-cho, Nishi-ku, Sakai City, Japan.
Masahito KotakaGastrointestinal Cancer Center, Sano Hospital, Shimizugaoka, Tarumi-ku, Kobe City, Hyogo, Japan.
Masayuki HirakiDepartment of Surgery, Itami City Hospital, Koyaike, Itami City, Hyogo, Japan.
Ken KonishiDepartment of Surgery, Hyogo Prefectural Nishinomiya Hospital, Rokutanji-cho, Nishinomiya City, Hyogo, Japan.
Shiro NakaeDepartment of Medical Oncology, Mimihara General Hospital, Kyowa-cho, Sakai-ku, Sakai City, Osaka, Japan.
Daisuke SakaiDepartment of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Yamadaoka, Suita City, Osaka, Japan.
Yukinori KurokawaDepartment of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Yamadaoka, Suita City, Osaka, Japan.
Toshio ShimokawaDepartment of Medical Data Science, Graduate School of Medicine, Wakayama Medical University, Kimiidera, Wakayama, Japan.
Taroh SatohDepartment of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Yamadaoka, Suita City, Osaka, Japan.
Osaka University · JPOsaka Medical and Pharmaceutical University · JPOsaka National Hospital · JPEbara (Japan) · JPFukushima Medical University Hospital · JPHigashi Osaka City General Hospital · JPHyogo Prefectural Nishinomiya Hospital · JPItami City Hospital · JPKansai Rosai Hospital · JPKindai University Hospital · JPKobe City Medical Center General Hospital · JPOsaka Rosai Hospital · JPSaiseikaisenri Hospital · JPSakai Municipal Hospital · JPShizuoka Cancer Center · JPWakayama Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedPanitumumab monotherapy showed favorable efficacy and feasibility in the treatment of frail or elderly patients with RAS wild-type unresectable colorectal cancer. It is especially effective for left-sided tumors; therefore, panitumumab as first-line treatment could be an additional therapeutic option for frail elderly patients, particularly in those who are unsuitable for upfront oxaliplatin-based or irinotecan-based combination regimens.

backgroundFirst-line panitumumab monotherapy is expected to be well tolerated and improve survival in patients ineligible for intensive chemotherapy. However, its safety and efficacy in chemotherapy-naïve frail or elderly patients with unresectable RAS wild-type (WT) colorectal cancer (CRC) have not been studied. The aim of this phase II trial was to evaluate the efficacy and safety of panitumumab as first-line treatment.

methodsWe conducted a multicenter phase II study on patients aged ≥76 years or ≥65 years considered unsuitable for intensive chemotherapy. Panitumumab 6 mg/kg of intravenous infusion was administered every 2 weeks. The primary endpoint was disease control rate (DCR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), response rate (RR), time to treatment failure (TTF), and incidence of grade 3 or 4 toxicities.

resultsThirty-six patients (median age: 81 [range, 67-88] years) were enrolled between February 2017 and August 2018. Two patients were excluded from the analysis of efficacy: one from lack of image examination at baseline and the other from lack of a measurable lesion. Thirty-three (91.6%) patients had a performance status (PS) of 0 or 1, whereas two (5.6%) patients and one (2.8%) patient had a PS of 2 and 3, respectively. Twenty-eight patients (77.8%) had left-sided CRC, whereas eight (22.2%) had right-sided CRC. The RR was 50.0% (95% confidence interval [CI], 32.4-67.6), including three patients (8.8%) who had complete responses. A total of 26.5% had stable diseases, resulting in a DCR of 76.5% (90% CI, 61.5-87.7). The RR of patients with left- and right-sided tumors was 65.4% (95% CI, 44.3-82.8) and 0.0% (95% CI, 0.0-36.9), respectively. Major grade 3 or 4 nonhematologic toxicities were rash (n = 6, 16.7%), hypomagnesemia (n = 4, 11.1%), fatigue (n = 3, 8.3%), paronychia (n = 2, 5.6%), and hyponatremia (n = 2, 5.6%). The only grade 3 hematologic toxicity was neutropenia (n = 1, 2.8%).

conclusionPanitumumab monotherapy showed favorable efficacy and feasibility in frail or elderly patients with RAS WT unresectable CRC. Survival analysis including OS, PFS, and TTF is currently in progress.

Indexed as

Colorectal NeoplasmsFrail ElderlyAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsHumansOxaliplatinPanitumumabProgression-Free SurvivalTreatment OutcomeOxaliplatinPanitumumabColorectal cancerElderly patientsOGSG1602PanitumumabRAS wild-type

Identifiers

PMID32918848
PMCPMC7794186
OpenAlexW3086762123

What OpenQuestion holds

Textmetadata
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.