Dual Targeting of the EGFR/HER2 Pathway in Combination with Systemic Chemotherapy in Refractory Pancreatic Cancer-The CONKO-008 Phase I Investigation

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Dual Targeting of the EGFR/HER2 Pathway in Combination with Systemic Chemotherapy in Refractory Pancreatic Cancer-The CONKO-008 Phase I Investigation. / Striefler, Jana K; Stieler, Jens M; Neumann, Christopher C M; Geisel, Dominik; Ghadjar, Pirus; Sinn, Marianne; Malinka, Thomas; Pratschke, Johann; Stintzing, Sebastian; Oettle, Helmut; Riess, Hanno; Pelzer, Uwe.

In: J CLIN MED, Vol. 11, No. 16, 4905, 21.08.2022.

Research output: SCORING: Contribution to journalSCORING: Journal articleResearchpeer-review

Harvard

Striefler, JK, Stieler, JM, Neumann, CCM, Geisel, D, Ghadjar, P, Sinn, M, Malinka, T, Pratschke, J, Stintzing, S, Oettle, H, Riess, H & Pelzer, U 2022, 'Dual Targeting of the EGFR/HER2 Pathway in Combination with Systemic Chemotherapy in Refractory Pancreatic Cancer-The CONKO-008 Phase I Investigation', J CLIN MED, vol. 11, no. 16, 4905. https://doi.org/10.3390/jcm11164905

APA

Striefler, J. K., Stieler, J. M., Neumann, C. C. M., Geisel, D., Ghadjar, P., Sinn, M., Malinka, T., Pratschke, J., Stintzing, S., Oettle, H., Riess, H., & Pelzer, U. (2022). Dual Targeting of the EGFR/HER2 Pathway in Combination with Systemic Chemotherapy in Refractory Pancreatic Cancer-The CONKO-008 Phase I Investigation. J CLIN MED, 11(16), [4905]. https://doi.org/10.3390/jcm11164905

Vancouver

Bibtex

@article{02b0c21b80a14148a4fa137a2f44fd32,
title = "Dual Targeting of the EGFR/HER2 Pathway in Combination with Systemic Chemotherapy in Refractory Pancreatic Cancer-The CONKO-008 Phase I Investigation",
abstract = "BACKGROUND: Primary objective of this present trial was to define the maximum tolerable dose of lapatinib in combination with oxaliplatin, 5-fluorouracil, and folinic acid (OFF) in refractory pancreatic cancer. The secondary objective was to assess the safety and efficacy of lapatinib plus OFF.METHODS: We conducted a phase I trial using an accelerated dose escalation design in patients with refractory pancreatic cancer. Lapatinib was given on days 1 to 42 in combination with folinic acid 200 mg/m2 day + 5-fluorouracil 2000 mg/m2 (24 h) on days 1, 8, 15, and 22, and oxaliplatin 85 mg/m2 days 8 and 22 of a 43-day cycle (OFF). Toxicity and efficacy were evaluated.RESULTS: In total, eighteen patients were enrolled: dose level 1 (1000 mg) was assigned to seven patients, dose level 2 (1250 mg), five patients; and dose level 3 (1500 mg), six patients. Dose-limiting toxicities were diarrhea and/or neutropenic enterocolitis observed in two of six patients: one diarrhea III°, one diarrhea IV°, as well as neutropenic enterocolitis. The maximum tolerable dose of lapatinib was 1250 mg OD.CONCLUSIONS: The combination of lapatinib 1250 mg OD with platinum-containing chemotherapy is safe and feasible in patients with refractory pancreatic cancer and warrants further investigation.",
author = "Striefler, {Jana K} and Stieler, {Jens M} and Neumann, {Christopher C M} and Dominik Geisel and Pirus Ghadjar and Marianne Sinn and Thomas Malinka and Johann Pratschke and Sebastian Stintzing and Helmut Oettle and Hanno Riess and Uwe Pelzer",
year = "2022",
month = aug,
day = "21",
doi = "10.3390/jcm11164905",
language = "English",
volume = "11",
journal = "J CLIN MED",
issn = "2077-0383",
publisher = "MDPI AG",
number = "16",

}

RIS

TY - JOUR

T1 - Dual Targeting of the EGFR/HER2 Pathway in Combination with Systemic Chemotherapy in Refractory Pancreatic Cancer-The CONKO-008 Phase I Investigation

AU - Striefler, Jana K

AU - Stieler, Jens M

AU - Neumann, Christopher C M

AU - Geisel, Dominik

AU - Ghadjar, Pirus

AU - Sinn, Marianne

AU - Malinka, Thomas

AU - Pratschke, Johann

AU - Stintzing, Sebastian

AU - Oettle, Helmut

AU - Riess, Hanno

AU - Pelzer, Uwe

PY - 2022/8/21

Y1 - 2022/8/21

N2 - BACKGROUND: Primary objective of this present trial was to define the maximum tolerable dose of lapatinib in combination with oxaliplatin, 5-fluorouracil, and folinic acid (OFF) in refractory pancreatic cancer. The secondary objective was to assess the safety and efficacy of lapatinib plus OFF.METHODS: We conducted a phase I trial using an accelerated dose escalation design in patients with refractory pancreatic cancer. Lapatinib was given on days 1 to 42 in combination with folinic acid 200 mg/m2 day + 5-fluorouracil 2000 mg/m2 (24 h) on days 1, 8, 15, and 22, and oxaliplatin 85 mg/m2 days 8 and 22 of a 43-day cycle (OFF). Toxicity and efficacy were evaluated.RESULTS: In total, eighteen patients were enrolled: dose level 1 (1000 mg) was assigned to seven patients, dose level 2 (1250 mg), five patients; and dose level 3 (1500 mg), six patients. Dose-limiting toxicities were diarrhea and/or neutropenic enterocolitis observed in two of six patients: one diarrhea III°, one diarrhea IV°, as well as neutropenic enterocolitis. The maximum tolerable dose of lapatinib was 1250 mg OD.CONCLUSIONS: The combination of lapatinib 1250 mg OD with platinum-containing chemotherapy is safe and feasible in patients with refractory pancreatic cancer and warrants further investigation.

AB - BACKGROUND: Primary objective of this present trial was to define the maximum tolerable dose of lapatinib in combination with oxaliplatin, 5-fluorouracil, and folinic acid (OFF) in refractory pancreatic cancer. The secondary objective was to assess the safety and efficacy of lapatinib plus OFF.METHODS: We conducted a phase I trial using an accelerated dose escalation design in patients with refractory pancreatic cancer. Lapatinib was given on days 1 to 42 in combination with folinic acid 200 mg/m2 day + 5-fluorouracil 2000 mg/m2 (24 h) on days 1, 8, 15, and 22, and oxaliplatin 85 mg/m2 days 8 and 22 of a 43-day cycle (OFF). Toxicity and efficacy were evaluated.RESULTS: In total, eighteen patients were enrolled: dose level 1 (1000 mg) was assigned to seven patients, dose level 2 (1250 mg), five patients; and dose level 3 (1500 mg), six patients. Dose-limiting toxicities were diarrhea and/or neutropenic enterocolitis observed in two of six patients: one diarrhea III°, one diarrhea IV°, as well as neutropenic enterocolitis. The maximum tolerable dose of lapatinib was 1250 mg OD.CONCLUSIONS: The combination of lapatinib 1250 mg OD with platinum-containing chemotherapy is safe and feasible in patients with refractory pancreatic cancer and warrants further investigation.

U2 - 10.3390/jcm11164905

DO - 10.3390/jcm11164905

M3 - SCORING: Journal article

C2 - 36013144

VL - 11

JO - J CLIN MED

JF - J CLIN MED

SN - 2077-0383

IS - 16

M1 - 4905

ER -