Evidence map›Paper›PMID 39516689›Full record

ArticleBJC reports2024

A Phase 2 study of nivolumab in combination with modified FOLFIRINOX for metastatic pancreatic cancer.

Chigusa Morizane, Makoto Ueno, Masafumi Ikeda, Kentaro Sudo, Yoshinori Hirashima, Masataka Kuroda, Shinji Ueno, Takuji Okusaka, Junji Furuse

Abstract read
In one paragraph

Article in BJC reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

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

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Clinical immunotherapy in pancreatic cancer.Cancer immunology, immunotherapy : CII · 2024
    Review
  9. Review
  10. Review
  11. Review
  12. The Role of Immunotherapy in Pancreatic Cancer.Current oncology (Toronto, Ont.) · 2022
    Review
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

9 authors.

Chigusa MorizaneDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan. cmorizan@ncc.go.jp.
Makoto UenoDepartment of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, Yokohama, Japan.
Masafumi IkedaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Kentaro SudoDepartment of Gastroenterology, Chiba Cancer Center, Chiba, Japan.
Yoshinori HirashimaClinical Development Headquarters, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Masataka KurodaClinical Development Headquarters, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Shinji UenoClinical Development Headquarters, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Takuji OkusakaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Junji FuruseDepartment of Medical Oncology, Kyorin University Faculty of Medicine, Mitaka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNivolumab with modified FOLFIRINOX (mFOLFIRINOX) may have additive antitumour effects while minimising chemotherapy cytotoxicity. We assessed the efficacy and safety of nivolumab+mFOLFIRINOX in metastatic pancreatic cancer.

methodsThirty-one treatment-naïve patients aged ≥20 years with metastatic unresectable/recurrent pancreatic cancer (≥1 measurable lesion per Response Evaluation Criteria in Solid Tumours version 1.1) and Eastern Cooperative Oncology Group 0/1 score and life expectancy ≥90 days received nivolumab (480 mg, every 4 weeks) plus mFOLFIRINOX. The primary endpoint was objective response rate (ORR). Secondary endpoints included overall survival (OS), progression-free survival (PFS) and safety.

resultsAt the median follow-up of 13.4 months, the ORR was 32.3% (complete response 0%; partial response 32.3%) and the median duration of response was 7.4 (range: 3.5-21.9) months; the primary endpoint was not met. Median OS and PFS were 13.4 (95% confidence interval [CI]: 10.6-16.6) months and 7.4 (95% CI: 3.9-9.2) months, respectively. The 1-year survival rate was 54.8% (95% CI: 36.0%-70.3%). Drug-related serious adverse events were reported in 29.0% of the patients; 3.2% drug-related adverse events led to discontinuation, and none led to death within 30-day safety window.

conclusionNivolumab+mFOLFIRINOX was tolerable in patients with metastatic pancreatic cancer. ORR and survival were comparable to previously reported data. (JapicCTI-184230).

Identifiers

PMID39516689
PMCPMC11524122

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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.