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Adding cetuximab to paclitaxel and carboplatin for first-line treatment of carcinoma of unknown primary (CUP): results of the Phase 2 AIO trial PACET-CUP

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Adding cetuximab to paclitaxel and carboplatin for first-line treatment of carcinoma of unknown primary (CUP): results of the Phase 2 AIO trial PACET-CUP. / Folprecht, Gunnar; Trautmann, Karolin; Stein, Alexander; Huebner, Gerdt; Stahl, Michael; Kasper, Stefan; Kretzschmar, Albrecht; Köhne, Claus-Henning; Grünwald, Viktor; Hofheinz, Ralf-Dieter; Schütte, Katharina; Löffler, Harald; Bokemeyer, Carsten; Krämer, Alwin; Arbeitsgemeinschaft Internistische Onkologie (AIO) - CUP Group.

In: BRIT J CANCER, Vol. 124, No. 4, 02.2021, p. 721-727.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Folprecht, G, Trautmann, K, Stein, A, Huebner, G, Stahl, M, Kasper, S, Kretzschmar, A, Köhne, C-H, Grünwald, V, Hofheinz, R-D, Schütte, K, Löffler, H, Bokemeyer, C, Krämer, A & Arbeitsgemeinschaft Internistische Onkologie (AIO) - CUP Group 2021, 'Adding cetuximab to paclitaxel and carboplatin for first-line treatment of carcinoma of unknown primary (CUP): results of the Phase 2 AIO trial PACET-CUP', BRIT J CANCER, vol. 124, no. 4, pp. 721-727. https://doi.org/10.1038/s41416-020-01141-8

APA

Folprecht, G., Trautmann, K., Stein, A., Huebner, G., Stahl, M., Kasper, S., Kretzschmar, A., Köhne, C-H., Grünwald, V., Hofheinz, R-D., Schütte, K., Löffler, H., Bokemeyer, C., Krämer, A., & Arbeitsgemeinschaft Internistische Onkologie (AIO) - CUP Group (2021). Adding cetuximab to paclitaxel and carboplatin for first-line treatment of carcinoma of unknown primary (CUP): results of the Phase 2 AIO trial PACET-CUP. BRIT J CANCER, 124(4), 721-727. https://doi.org/10.1038/s41416-020-01141-8

Vancouver

Folprecht G, Trautmann K, Stein A, Huebner G, Stahl M, Kasper S et al. Adding cetuximab to paclitaxel and carboplatin for first-line treatment of carcinoma of unknown primary (CUP): results of the Phase 2 AIO trial PACET-CUP. BRIT J CANCER. 2021 Feb;124(4):721-727. https://doi.org/10.1038/s41416-020-01141-8

Bibtex

@article{984233bf8c4642f88e5c9144a66281c7,
title = "Adding cetuximab to paclitaxel and carboplatin for first-line treatment of carcinoma of unknown primary (CUP): results of the Phase 2 AIO trial PACET-CUP",
abstract = "BACKGROUND: Patients with carcinoma of unknown primary (CUP) have a dismal prognosis, even when treated with multi-agent chemotherapy. We hypothesised that adding the epidermal growth-factor receptor (EGFR) inhibitor cetuximab to standard first-line chemotherapy with paclitaxel and carboplatin would improve PFS and RR in unfavourable CUP.METHODS: This open-labelled, multicentre Phase 2 study included patients with unfavourable, untreated adeno- or undifferentiated CUP. Patients were randomised to receive either paclitaxel/carboplatin (group A) or paclitaxel/carboplatin plus cetuximab (group B) every 3 weeks for a maximum of 6 cycles followed by cetuximab maintenance in group B. The primary endpoint was PFS in the two groups. Secondary endpoints were RR, toxicity and overall survival (OS).RESULTS: One-hundred-and-fifty patients were randomised (group A = 72, group B = 78). The median PFS and OS for all patients were 3.8 and 8.1 months (95% confidence interval (CI): 2.9-4.8 and 6.8-9.5). There was no significant difference in PFS (3.7 vs 4.6 months, HR 0.98) or OS (8.1 vs 7.4, HR 1.1) between the two treatment groups. Response rate tended to be better for chemotherapy plus cetuximab compared to chemotherapy alone (22% vs 15%). Adverse events grade ≥3 were comparable between the two groups, except for significantly increased skin toxicity in the cetuximab arm.CONCLUSIONS: Cetuximab plus paclitaxel/carboplatin did not improve PFS, OS and RR in metastatic CUP compared to paclitaxel/carboplatin alone. Addition of cetuximab resulted in additional skin toxicity.CLINICAL TRIAL REGISTRATION: The study was registered at clinicaltrials.gov as NCT00894569.",
author = "Gunnar Folprecht and Karolin Trautmann and Alexander Stein and Gerdt Huebner and Michael Stahl and Stefan Kasper and Albrecht Kretzschmar and Claus-Henning K{\"o}hne and Viktor Gr{\"u}nwald and Ralf-Dieter Hofheinz and Katharina Sch{\"u}tte and Harald L{\"o}ffler and Carsten Bokemeyer and Alwin Kr{\"a}mer and {Arbeitsgemeinschaft Internistische Onkologie (AIO) - CUP Group}",
year = "2021",
month = feb,
doi = "10.1038/s41416-020-01141-8",
language = "English",
volume = "124",
pages = "721--727",
journal = "BRIT J CANCER",
issn = "0007-0920",
publisher = "NATURE PUBLISHING GROUP",
number = "4",

}

RIS

TY - JOUR

T1 - Adding cetuximab to paclitaxel and carboplatin for first-line treatment of carcinoma of unknown primary (CUP): results of the Phase 2 AIO trial PACET-CUP

AU - Folprecht, Gunnar

AU - Trautmann, Karolin

AU - Stein, Alexander

AU - Huebner, Gerdt

AU - Stahl, Michael

AU - Kasper, Stefan

AU - Kretzschmar, Albrecht

AU - Köhne, Claus-Henning

AU - Grünwald, Viktor

AU - Hofheinz, Ralf-Dieter

AU - Schütte, Katharina

AU - Löffler, Harald

AU - Bokemeyer, Carsten

AU - Krämer, Alwin

AU - Arbeitsgemeinschaft Internistische Onkologie (AIO) - CUP Group

PY - 2021/2

Y1 - 2021/2

N2 - BACKGROUND: Patients with carcinoma of unknown primary (CUP) have a dismal prognosis, even when treated with multi-agent chemotherapy. We hypothesised that adding the epidermal growth-factor receptor (EGFR) inhibitor cetuximab to standard first-line chemotherapy with paclitaxel and carboplatin would improve PFS and RR in unfavourable CUP.METHODS: This open-labelled, multicentre Phase 2 study included patients with unfavourable, untreated adeno- or undifferentiated CUP. Patients were randomised to receive either paclitaxel/carboplatin (group A) or paclitaxel/carboplatin plus cetuximab (group B) every 3 weeks for a maximum of 6 cycles followed by cetuximab maintenance in group B. The primary endpoint was PFS in the two groups. Secondary endpoints were RR, toxicity and overall survival (OS).RESULTS: One-hundred-and-fifty patients were randomised (group A = 72, group B = 78). The median PFS and OS for all patients were 3.8 and 8.1 months (95% confidence interval (CI): 2.9-4.8 and 6.8-9.5). There was no significant difference in PFS (3.7 vs 4.6 months, HR 0.98) or OS (8.1 vs 7.4, HR 1.1) between the two treatment groups. Response rate tended to be better for chemotherapy plus cetuximab compared to chemotherapy alone (22% vs 15%). Adverse events grade ≥3 were comparable between the two groups, except for significantly increased skin toxicity in the cetuximab arm.CONCLUSIONS: Cetuximab plus paclitaxel/carboplatin did not improve PFS, OS and RR in metastatic CUP compared to paclitaxel/carboplatin alone. Addition of cetuximab resulted in additional skin toxicity.CLINICAL TRIAL REGISTRATION: The study was registered at clinicaltrials.gov as NCT00894569.

AB - BACKGROUND: Patients with carcinoma of unknown primary (CUP) have a dismal prognosis, even when treated with multi-agent chemotherapy. We hypothesised that adding the epidermal growth-factor receptor (EGFR) inhibitor cetuximab to standard first-line chemotherapy with paclitaxel and carboplatin would improve PFS and RR in unfavourable CUP.METHODS: This open-labelled, multicentre Phase 2 study included patients with unfavourable, untreated adeno- or undifferentiated CUP. Patients were randomised to receive either paclitaxel/carboplatin (group A) or paclitaxel/carboplatin plus cetuximab (group B) every 3 weeks for a maximum of 6 cycles followed by cetuximab maintenance in group B. The primary endpoint was PFS in the two groups. Secondary endpoints were RR, toxicity and overall survival (OS).RESULTS: One-hundred-and-fifty patients were randomised (group A = 72, group B = 78). The median PFS and OS for all patients were 3.8 and 8.1 months (95% confidence interval (CI): 2.9-4.8 and 6.8-9.5). There was no significant difference in PFS (3.7 vs 4.6 months, HR 0.98) or OS (8.1 vs 7.4, HR 1.1) between the two treatment groups. Response rate tended to be better for chemotherapy plus cetuximab compared to chemotherapy alone (22% vs 15%). Adverse events grade ≥3 were comparable between the two groups, except for significantly increased skin toxicity in the cetuximab arm.CONCLUSIONS: Cetuximab plus paclitaxel/carboplatin did not improve PFS, OS and RR in metastatic CUP compared to paclitaxel/carboplatin alone. Addition of cetuximab resulted in additional skin toxicity.CLINICAL TRIAL REGISTRATION: The study was registered at clinicaltrials.gov as NCT00894569.

U2 - 10.1038/s41416-020-01141-8

DO - 10.1038/s41416-020-01141-8

M3 - SCORING: Journal article

C2 - 33235314

VL - 124

SP - 721

EP - 727

JO - BRIT J CANCER

JF - BRIT J CANCER

SN - 0007-0920

IS - 4

ER -