Evidence map›Paper›PMID 41661417›Full record

Trial reportInternational journal of clinical oncology2026

Modified EXTREME regimen versus modified TPEx regimen as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, open-label, randomized, exploratory study (TEMPER study).

Motoyuki Suzuki, Akehito Kishino, Masashi Sugasawa, Takashi Fujii, Ayako Nakanome, Tomonori Terada, Hitoshi Hirakawa, Yushi Ueki, Mioko Matsuo, Rie Ito and 13 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

23 authors.

Motoyuki SuzukiDepartment of Otorhinolaryngology-Head and Neck Surgery, The University of Osaka, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.ORCID http://orcid.org/0000-0001-9747-6993
Akehito KishinoDepartment of Otolaryngology, Faculty of Medicine, Kagawa University, Kagawa, Japan.
Masashi SugasawaDepartment of Head and Neck Surgery, International Medical Center, Saitama Medical University, Saitama, Japan.
Takashi FujiiDepartment of Head and Neck Surgery, Osaka International Cancer Institute, Osaka Prefectural Hospital Organization, Osaka, Japan.
Ayako NakanomeDepartment of Otolaryngology-Head and Neck Surgery, Tohoku University Graduate School of Medicine, Miyagi, Japan.
Tomonori TeradaDepartment of Otolaryngology-Head and Neck Surgery, Hyogo Medical University, Hyogo, Japan.
Hitoshi HirakawaDepartment of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, University of the Ryukyus, Okinawa, Japan.
Yushi UekiDepartment of Otolaryngology, Head and Neck Surgery, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
Mioko MatsuoDepartment of Otorhinolaryngology Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Rie ItoDepartment of Otorhinolaryngology-Head and Neck Surgery, Osaka Rosai Hospital, Osaka, Japan.
Muneki HotomiDepartment of Otorhinolaryngology Head and Neck Surgery, Wakayama Medical University, Wakayama, Japan.
Masafumi KannoDepartment of Otorhinolaryngology-Head and Neck Surgery, Medical Science, University of Fukui, Fukui, Japan.
Akihito WatanabeDepartment of Otolaryngology-Head and Neck Surgery, Keiyukai Sapporo Hospital, Sapporo, Japan.
Yoshiaki KitamuraDepartment of Otorhinolaryngology-Head and Neck Surgery, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.
Kenji OkamiDepartment of Otolaryngology, Head and Neck Surgery, School of Medicine, Tokai University, Kanagawa, Japan.
Kazuhira EndoDivision of Otolaryngology-Head and Neck Surgery, School of Medicine, Kanazawa University, Ishikawa, Japan.
Takeharu OnoDepartment of Otolaryngology-Head and Neck Surgery, Kurume University School of Medicine, Fukuoka, Japan.
Shigeru HiranoDepartment of Otolaryngology Head and Neck Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Go OmuraDepartment of Head and Neck Surgery, National Cancer Center Hospital, Tokyo, Japan.
Koichi OmoriDepartment of Head and Neck Oncology and Innovative Treatment, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Yoshifumi YamamotoOsaka General Medical Center Department of Otorhinolaryngology-Head and Neck Surgery, Osaka, Japan.
Mototsugu ShimokawaDepartment of Biostatistics, Yamaguchi University Graduate School of Medicine, Ube, Japan.
Hidenori InoharaDepartment of Otorhinolaryngology-Head and Neck Surgery, The University of Osaka, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. hinohara@ent.med.osaka-u.ac.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe EXTREME regimen is the standard first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC), but it is poorly tolerated in Asian patients. We aimed to compare the efficacy and safety of the modified EXTREME (mEXTREME) and modified TPEx (mTPEx) regimens in Japanese patients.

methodsThis was a multicenter, randomized, exploratory study. The dose of chemotherapeutic agents was reduced by 25% for the mEXTREME regimen compared to the EXTREME regimen and by 20% for the mTPEX regimen compared to the TPEx regimen. Six and four cycles were repeated every 21 days for the mEXTREME and mTPEx regimens, respectively. In both regimens, weekly 250 mg/m

resultsSixty-one patients were enrolled and assigned to the two treatment arms (30 to mEXTREME, 31 to mTPEx). Median PFS was 6.0 months and 5.3 months (p = 0.28), and median overall survival was 17.4 months and 18.7 months (p = 0.72) for the mEXTREME and mTPEx groups, respectively. Twenty-seven patients in the mEXTREME group and 29 patients in the mTPEx group had grade 3 or worse adverse events during chemotherapy (p = 0.61). Early tumor shrinkage was 20% in the mEXTREME group and 44% in the mTPEx group (p = 0.01).

conclusionsNo significant differences in survival were observed between the two groups, with similar toxicity profiles. As early tumor shrinkage was favorable in the mTPEx group, the mTPEx regimen may be the first-line standard of care for Asian patients with R/M HNSCC, particularly those who are not candidates for up-front pembrolizumab due to CPS < 1 or the presence of immunologically related complications and those who need rapid tumor shrinkage to relieve tumor-related symptoms.

trial registrationUMIN000025436.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsHead and Neck NeoplasmsNeoplasm Recurrence, LocalSquamous Cell Carcinoma of Head and NeckAdultAgedCetuximabCisplatinDocetaxelFemaleHumansMaleMiddle AgedNeoplasm MetastasisPaclitaxelCetuximabCisplatinDocetaxelPaclitaxelFirst-line treatmentModified EXTREMEModified TPExRecurrent or metastatic squamous cell carcinoma of the head and neck

Identifiers

PMID41661417
PMCPMC13018074

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