PICCA study: panitumumab in combination with cisplatin/gemcitabine chemotherapy in KRAS wild-type patients with biliary cancer—a randomised biomarker-driven clinical phase II AIO study

Vogel, Arndt; Kasper, Stefan; Bitzer, Michael; Block, Andreas; Sinn, Marianne; Schulze‐Bergkamen, Henning; Moehler, Markus; Pfarr, Nicole; Endris, Volker; Goeppert, Benjamin; Merx, Kirsten; Schnoy, Elisabeth; Siveke, Jens T.; Michl, Patrick; Waldschmidt, Dirk; Kuhlmann, Jan; Geißler, Michael; Kahl, Christoph; Evenkamp, Ralph; Schmidt, Torben; Kuhlmann, Alexander; Weichert, Wilko; Kubicka, Stefan

doi:10.1016/j.ejca.2017.12.028

Cited by 56 publications

(40 citation statements)

References 13 publications

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“…This left four RCTs to be included after independent evaluation of two Authors (A.R. and G.F.) (33)(34)(35)(36). Figure 3 shows the search process.…”

Section: Resultsmentioning

confidence: 99%

“…A total of four RCTs comparing gemcitabine-based CHT plus EGFR-mAbs with gemcitabine-based CHT as first-line treatment were selected, including a total of 450 patients (228 in the combination arm, 222 in the gemcitabine-based CHT alone arm) (33)(34)(35)(36). Both published full articles and study protocols were available in all four studies.…”

Section: Resultsmentioning

confidence: 99%

“…Both published full articles and study protocols were available in all four studies. One study in vivo 34: 479-488 (2020) was conducted in Italy (34), one in Taiwan (33), one in Germany (36) and one in France and Germany (35). All of the studies provided complete data for OS analysis, for PFS analysis and for grade 3-4 toxicities; three studies provided complete data for ORR.…”

Section: Resultsmentioning

confidence: 99%

“…A summary of the included RCTs is presented in Table I. OS. Four studies provided OS data on 450 patients affected by advanced BTC (33)(34)(35)(36). The median OS ranged from 9.9 to 12.8 months in the combination of gemcitabine-based CHT with EGFR-mAbs and was 9.8-20.8 months for CHT alone.…”

Section: Resultsmentioning

confidence: 99%

“…Several clinical trials have recently evaluated the role of EGFR-targeted drugs, usually divided into EGFR tyrosine kinase inhibitors (EGFR-TKIs) and monoclonal antibodies to EGFR (EGFR-mAbs), with disappointing results as monotherapy or in combination with chemotherapy (CHT) (32)(33)(34)(35)(36)(37). Anti-EGFR agents are widely used in head and neck cancer, lung and colorectal cancer, given the benefits provided by these targeted therapies in the advanced or metastatic setting (38)(39)(40)(41).…”

Section: Abstract Background: Despite Several Clinical Trials Andmentioning

confidence: 99%

See 4 more Smart Citations

Anti-EGFR Monoclonal Antibodies in Advanced Biliary Tract Cancer: A Systematic Review and Meta-analysis

Rizzo

Frega

Ricci

et al. 2020

In Vivo

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“…This left four RCTs to be included after independent evaluation of two Authors (A.R. and G.F.) (33)(34)(35)(36). Figure 3 shows the search process.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Abstract Background: Despite Several Clinical Trials Andmentioning

confidence: 99%

See 3 more Smart Citations

Anti-EGFR Monoclonal Antibodies in Advanced Biliary Tract Cancer: A Systematic Review and Meta-analysis

Rizzo

Frega

Ricci

et al. 2020

In Vivo

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Safety and efficacy of GEMOX plus donafenib and tislelizumab as first‐line therapy for advanced epithelial malignant biliary tract cancer

Wang

Zhang

et al. 2023

Cancer Medicine

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Aim: This study was aimed to evaluate the safety and the efficacy of gemcitabine and oxaliplatin (GEMOX) combined with donafenib plus tislelizumab as the firstline treatment for patients with unresectable biliary tract cancer (BTC).Methods: This is a prospective single-center exploratory study. Eligible patients (Stage III/IV BTC, at least one measurable disease according to RECIST v1.1, etc.) received gemcitabine 1000 mg/m 2 IV Q3W, oxaliplatin 100 mg/m 2 IV Q3W, donafenib 200 mg PO BID, and tislelizumab 200 mg IV Q3W until disease progression, unacceptable toxicity, or withdrawal of consent whichever occurred first. The primary endpoint was safety and secondary endpoints included disease control rate (DCR), objective response rate (ORR), conversion rate, and overall survival (OS).Results: A total of 13 patients were enrolled. The median follow-up time was 420 days (range 345-487). The median duration of treatment was four cycles (range 1-15). The incidence of ≥Grade 3 treatment-related adverse events (TRAEs) was 53.8% and no Grade 5 TRAE. The most frequent Grade 3-4 TRAEs were rash (4/13, 30.8%), platelet count decreased (2/13, 15.4%), and fatigue (2/13, 15.4%). Tumor response was assessed in eight evaluable patients; ORR was 25.0% (95% CI, 3.2%-65.1%) and DCR 87.5% (95% CI, 47.3%-99.7%). The median PFS was 4.8 months (95% CI, 1.25-NE). Three Stage III patients underwent subsequent surgery with a conversion rate of 23.1%. The median OS was not estimable.Conclusions: GEMOX combined with donafenib plus tislelizumab as the firstline therapy for unresectable BTC showed manageable toxicity and encouraging efficacy especially in terms of promising conversion rate in Stage III patients.

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Silmitasertib plus gemcitabine and cisplatin first‐line therapy in locally advanced/metastatic cholangiocarcinoma: A Phase 1b/2 study

et al. 2023

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Background and Aims: This study aimed to investigate safety and efficacy of silmitasertib, an oral small molecule casein kinase 2 inhibitor, plus gemcitabine and cisplatin (G+C) versus G+C in locally advanced/metastatic cholangiocarcinoma. Approach and Results: This work is a Phase 1b/2 study (S4-13-001). In Phase 2, patients received silmitasertib 1000 mg twice daily for 10 days with G+C on Days 1 and 8 of a 21-day cycle. Primary efficacy endpoint was progression-free survival (PFS) in the modified intent-to-treat population

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PICCA study: panitumumab in combination with cisplatin/gemcitabine chemotherapy in KRAS wild-type patients with biliary cancer—a randomised biomarker-driven clinical phase II AIO study

Cited by 56 publications

References 13 publications

Anti-EGFR Monoclonal Antibodies in Advanced Biliary Tract Cancer: A Systematic Review and Meta-analysis

Anti-EGFR Monoclonal Antibodies in Advanced Biliary Tract Cancer: A Systematic Review and Meta-analysis

Safety and efficacy of GEMOX plus donafenib and tislelizumab as first‐line therapy for advanced epithelial malignant biliary tract cancer

Silmitasertib plus gemcitabine and cisplatin first‐line therapy in locally advanced/metastatic cholangiocarcinoma: A Phase 1b/2 study

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