A phase II trial of gemcitabine and erlotinib followed by ChemoProton therapy plus capecitabine and oxaliplatin for locally advanced pancreatic cancer
2022 Journal of Gastrointestinal Oncology. All rights reserved..
Background: Epidermal growth factor receptor (EGFR) is overexpressed in pancreatic cancer. EGFR expression plays a potentially important role in modulation of tumor sensitivity to either chemotherapy or radiotherapy. Erlotinib is a receptor tyrosine kinase inhibitor with specificity for EGFR/HER1. A phase II trial was conducted to explore the efficacy of a regimen utilizing erlotinib and proton therapy.
Methods: Patients with unresectable or borderline resectable non-metastatic adenocarcinoma of the pancreas were included. Patients received 8-week systemic treatment with gemcitabine 1,000 mg/m2 and erlotinib 100 mg (GE). If there was no evidence of metastatic disease after GE, then patients preceded with proton therapy to 50.4 Gy in 28 fractions with concurrent capecitabine 825 mg/m2 (CPT). This was followed with oxaliplatin 130 mg/m2 and capecitabine 1,000 mg/m2 (CapOx) for 4 cycles. The primary study objective was 1-year overall survival (OS). The benchmark was 43% 1-year survival as demonstrated in RTOG/NRG 98-12. The Kaplan-Meier method was used to estimate the one-year OS and the median OS and progression-free survival (PFS).
Results: The study enrolled 9 patients ages 47-81 years old (median 62) between January 2013 and March 2016, when the trial was closed due to low patient accrual. The 1-year OS rate was 55.6% (95% CI: 31% to 99%). The median OS was 14.1 months (95% CI: 11.4-NE) and the median PFS was 10.8 months (95% CI: 7.44-NE). A majority of patients completed CPT and GE, but only 33.3% completed the four cycles of CapOx. A third of patients experienced grade 3 toxicities, which were all hepatic along with one patient who also had grade 3 diarrhea. There were no grade 4 or 5 toxicities. Four patients were enrolled with borderline resectable disease, three of which were eligible for pancreaticoduodenectomy after GE and CPT treatment. One of two patients who underwent resection had a negative margin.
Conclusions: This regimen for locally advanced pancreatic cancer (LAPC) exceeded the pre-specified benchmark and was safe and well tolerated. Additional investigations utilizing more current systemic treatment regimens with proton therapy are warranted.
Trial Registration: ClinicalTrials.gov identifier (NCTNCT01683422).
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
|---|---|
| Enthalten in: |
Journal of gastrointestinal oncology - 13(2022), 4 vom: 05. Aug., Seite 1989-1996 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Sanghvi, Samrat M [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Chemotherapy |
|---|
| Anmerkungen: |
Date Revised 13.09.2022 published: Print ClinicalTrials.gov: NCT01683422 Citation Status PubMed-not-MEDLINE |
|---|
| doi: |
10.21037/jgo-22-327 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM346092930 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM346092930 | ||
| 003 | DE-627 | ||
| 005 | 20231226030612.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2022 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.21037/jgo-22-327 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1153.xml |
| 035 | |a (DE-627)NLM346092930 | ||
| 035 | |a (NLM)36092320 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Sanghvi, Samrat M |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A phase II trial of gemcitabine and erlotinib followed by ChemoProton therapy plus capecitabine and oxaliplatin for locally advanced pancreatic cancer |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 13.09.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT01683422 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a 2022 Journal of Gastrointestinal Oncology. All rights reserved. | ||
| 520 | |a Background: Epidermal growth factor receptor (EGFR) is overexpressed in pancreatic cancer. EGFR expression plays a potentially important role in modulation of tumor sensitivity to either chemotherapy or radiotherapy. Erlotinib is a receptor tyrosine kinase inhibitor with specificity for EGFR/HER1. A phase II trial was conducted to explore the efficacy of a regimen utilizing erlotinib and proton therapy | ||
| 520 | |a Methods: Patients with unresectable or borderline resectable non-metastatic adenocarcinoma of the pancreas were included. Patients received 8-week systemic treatment with gemcitabine 1,000 mg/m2 and erlotinib 100 mg (GE). If there was no evidence of metastatic disease after GE, then patients preceded with proton therapy to 50.4 Gy in 28 fractions with concurrent capecitabine 825 mg/m2 (CPT). This was followed with oxaliplatin 130 mg/m2 and capecitabine 1,000 mg/m2 (CapOx) for 4 cycles. The primary study objective was 1-year overall survival (OS). The benchmark was 43% 1-year survival as demonstrated in RTOG/NRG 98-12. The Kaplan-Meier method was used to estimate the one-year OS and the median OS and progression-free survival (PFS) | ||
| 520 | |a Results: The study enrolled 9 patients ages 47-81 years old (median 62) between January 2013 and March 2016, when the trial was closed due to low patient accrual. The 1-year OS rate was 55.6% (95% CI: 31% to 99%). The median OS was 14.1 months (95% CI: 11.4-NE) and the median PFS was 10.8 months (95% CI: 7.44-NE). A majority of patients completed CPT and GE, but only 33.3% completed the four cycles of CapOx. A third of patients experienced grade 3 toxicities, which were all hepatic along with one patient who also had grade 3 diarrhea. There were no grade 4 or 5 toxicities. Four patients were enrolled with borderline resectable disease, three of which were eligible for pancreaticoduodenectomy after GE and CPT treatment. One of two patients who underwent resection had a negative margin | ||
| 520 | |a Conclusions: This regimen for locally advanced pancreatic cancer (LAPC) exceeded the pre-specified benchmark and was safe and well tolerated. Additional investigations utilizing more current systemic treatment regimens with proton therapy are warranted | ||
| 520 | |a Trial Registration: ClinicalTrials.gov identifier (NCTNCT01683422) | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Locally advanced pancreatic cancer (LAPC) | |
| 650 | 4 | |a chemotherapy | |
| 650 | 4 | |a erlotinib | |
| 650 | 4 | |a proton radiation therapy | |
| 650 | 4 | |a targeted therapy | |
| 700 | 1 | |a Coffman, Alex R |e verfasserin |4 aut | |
| 700 | 1 | |a Hsueh, Chung-Tsen |e verfasserin |4 aut | |
| 700 | 1 | |a Kang, Joseph |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Annie |e verfasserin |4 aut | |
| 700 | 1 | |a Solomon, Naveenraj L |e verfasserin |4 aut | |
| 700 | 1 | |a Garberoglio, Carlos A |e verfasserin |4 aut | |
| 700 | 1 | |a Reeves, Mark E |e verfasserin |4 aut | |
| 700 | 1 | |a Slater, Jerry D |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Gary Y |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of gastrointestinal oncology |d 2010 |g 13(2022), 4 vom: 05. Aug., Seite 1989-1996 |w (DE-627)NLM209547685 |x 2078-6891 |7 nnns |
| 773 | 1 | 8 | |g volume:13 |g year:2022 |g number:4 |g day:05 |g month:08 |g pages:1989-1996 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.21037/jgo-22-327 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 13 |j 2022 |e 4 |b 05 |c 08 |h 1989-1996 | ||