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Randomized Phase II trial of combination chemotherapy with panitumumab or bevacizumab for patients with inoperable biliary tract cancer without KRAS exon 2 mutations

Amin, Nadia Emad Lotfi ; Hansen, Torben Frøstrup ; Fernebro, Eva LU ; Ploen, John ; Eberhard, Jakob LU ; Lindebjerg, Jan and Jensen, Lars Henrik (2021) In International Journal of Cancer 149(1). p.119-126
Abstract

Biliary tract cancers (BTC) are rare and often diagnosed in late stages with advanced, nonresectable disease. The targeted agents panitumumab and bevacizumab have shown promising outcomes in combination with chemotherapy in other gastrointestinal (GI) cancers. We wanted to investigate if panitumumab or bevacizumab was the most promising drug to add to chemotherapy. Eighty-eight patients were randomized to combination chemotherapy supplemented by either panitumumab 6 mg/kg or bevacizumab 10 mg/kg on Day 1 in Arm A and Arm B, respectively. All patients received gemcitabine 1000 mg/m2 on Day 1, oxaliplatin 60 mg/m2 on Day 1 and capecitabine 1000 mg/m2 twice daily from Days 1 to 7. Treatment was repeated... (More)

Biliary tract cancers (BTC) are rare and often diagnosed in late stages with advanced, nonresectable disease. The targeted agents panitumumab and bevacizumab have shown promising outcomes in combination with chemotherapy in other gastrointestinal (GI) cancers. We wanted to investigate if panitumumab or bevacizumab was the most promising drug to add to chemotherapy. Eighty-eight patients were randomized to combination chemotherapy supplemented by either panitumumab 6 mg/kg or bevacizumab 10 mg/kg on Day 1 in Arm A and Arm B, respectively. All patients received gemcitabine 1000 mg/m2 on Day 1, oxaliplatin 60 mg/m2 on Day 1 and capecitabine 1000 mg/m2 twice daily from Days 1 to 7. Treatment was repeated every 2 weeks until progression or for a maximum of 6 months. At progression, crossover was made to the other treatment arm. The primary endpoint was progression-free survival (PFS) at 6 months. With 19 of 45 in Arm A and 23 of 43 in Arm B PFS at 6 months, the primary endpoint was not met. The overall response rate (ORR) was 45% vs 20% (P =.03), median PFS was 6.1 months vs 8.2 months (P =.13) and median overall survival (OS) was 9.5 months vs 12.3 months (P =.47) in Arm A and Arm B, respectively. Our study showed no consistent differences between adding panitumumab or bevacizumab to chemotherapy in nonresectable BTC and none of the two regimens qualify for testing in Phase III. However, we found a higher response rate in the panitumumab arm with potential implication for future trials in the neoadjuvant setting.

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author
; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
bevacizumab, biliary tract cancer, biological agents, chemotherapy, cholangiocarcinoma, KRAS, panitumumab, targeted therapy
in
International Journal of Cancer
volume
149
issue
1
pages
8 pages
publisher
John Wiley & Sons Inc.
external identifiers
  • pmid:33561312
  • scopus:85101253932
ISSN
0020-7136
DOI
10.1002/ijc.33509
language
English
LU publication?
yes
id
ba9f8c25-58bf-474a-a8a1-dd8ba28f2ce2
date added to LUP
2021-03-10 14:24:02
date last changed
2024-04-18 03:32:14
@article{ba9f8c25-58bf-474a-a8a1-dd8ba28f2ce2,
  abstract     = {{<p>Biliary tract cancers (BTC) are rare and often diagnosed in late stages with advanced, nonresectable disease. The targeted agents panitumumab and bevacizumab have shown promising outcomes in combination with chemotherapy in other gastrointestinal (GI) cancers. We wanted to investigate if panitumumab or bevacizumab was the most promising drug to add to chemotherapy. Eighty-eight patients were randomized to combination chemotherapy supplemented by either panitumumab 6 mg/kg or bevacizumab 10 mg/kg on Day 1 in Arm A and Arm B, respectively. All patients received gemcitabine 1000 mg/m<sup>2</sup> on Day 1, oxaliplatin 60 mg/m<sup>2</sup> on Day 1 and capecitabine 1000 mg/m<sup>2</sup> twice daily from Days 1 to 7. Treatment was repeated every 2 weeks until progression or for a maximum of 6 months. At progression, crossover was made to the other treatment arm. The primary endpoint was progression-free survival (PFS) at 6 months. With 19 of 45 in Arm A and 23 of 43 in Arm B PFS at 6 months, the primary endpoint was not met. The overall response rate (ORR) was 45% vs 20% (P =.03), median PFS was 6.1 months vs 8.2 months (P =.13) and median overall survival (OS) was 9.5 months vs 12.3 months (P =.47) in Arm A and Arm B, respectively. Our study showed no consistent differences between adding panitumumab or bevacizumab to chemotherapy in nonresectable BTC and none of the two regimens qualify for testing in Phase III. However, we found a higher response rate in the panitumumab arm with potential implication for future trials in the neoadjuvant setting.</p>}},
  author       = {{Amin, Nadia Emad Lotfi and Hansen, Torben Frøstrup and Fernebro, Eva and Ploen, John and Eberhard, Jakob and Lindebjerg, Jan and Jensen, Lars Henrik}},
  issn         = {{0020-7136}},
  keywords     = {{bevacizumab; biliary tract cancer; biological agents; chemotherapy; cholangiocarcinoma; KRAS; panitumumab; targeted therapy}},
  language     = {{eng}},
  month        = {{07}},
  number       = {{1}},
  pages        = {{119--126}},
  publisher    = {{John Wiley & Sons Inc.}},
  series       = {{International Journal of Cancer}},
  title        = {{Randomized Phase II trial of combination chemotherapy with panitumumab or bevacizumab for patients with inoperable biliary tract cancer without KRAS exon 2 mutations}},
  url          = {{http://dx.doi.org/10.1002/ijc.33509}},
  doi          = {{10.1002/ijc.33509}},
  volume       = {{149}},
  year         = {{2021}},
}