Randomized phase IIA trial of gemcitabine compared with bleomycin plus vincristine for treatment of Kaposi's sarcoma in patients on combination antiretroviral therapy in western Kenya

Naftali W. Busakhala, Paul J. Waako, Matthew Robert Strother, Alfred Kipyegon Keter, Gabriel Kimutai Kigen, Fredrick Chite Asirwa, Patrick Loehrer

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Purpose: Kaposi's sarcoma (KS) is a spindle cell tumor resulting from growth dysregulation in the setting of infection with human herpes virus-8 (also called KS herpes virus). Advanced KS is characterized by poor responses to antiretroviral therapy and some of the chemotherapy readily accessible to patients in low-resource areas. Gemcitabine induced partial and complete regression of AIDS-associated KS (AIDS-KS) in 11 of 24 patients in a pilot study. The current study compares the antimetabolite gemcitabine with the standard care bleomycin and vincristine (BV) in the treatment of chemotherapy-naïve patients with AIDS-KS in a resource-limited setting. Patients and Methods: Patients with persistent or progressive KS despite treatment with combined antiretroviral therapy were randomly assigned to receive gemcitabine 1,000 mg/m2 or bleomycin 15 IU/ m2 and vincristine 1.4 mg/m2 given twice weekly. The main end point was objective response by bidirectional measurement, adverse events, and quality of life after three cycles of chemotherapy. Results: Of 70 participants enrolled, 36 received gemcitabine and 34 received BV. Complete response was achieved in 12 patients (33.3%) in the gemcitabine arm and six (17.6%) in the BV arm (P = .175). The partial response rate was 52.8% (n = 19) in the gemcitabine arm and 58.8% (n = 20) in the BV arm. Both study arms reported similar neurologic and hematologic adverse events; there was statistically significant baseline to post-treatment improvement in health-related quality-of-life scores. Conclusion: The results of this randomized, phase IIA trial demonstrate gemcitabine activity in chemotherapy-naïve patients with AIDS-KS, on the basis of response rates, adverse events, and health-related quality-of-life scores.

Original languageEnglish (US)
JournalJournal of global oncology
Volume2018
Issue number4
DOIs
StatePublished - Mar 1 2018
Externally publishedYes

Fingerprint

gemcitabine
Kaposi's Sarcoma
Kenya
Bleomycin
Vincristine
Drug Therapy
Acquired Immunodeficiency Syndrome
Quality of Life
Therapeutics
Viruses
Antimetabolites
Nervous System

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Randomized phase IIA trial of gemcitabine compared with bleomycin plus vincristine for treatment of Kaposi's sarcoma in patients on combination antiretroviral therapy in western Kenya. / Busakhala, Naftali W.; Waako, Paul J.; Strother, Matthew Robert; Keter, Alfred Kipyegon; Kigen, Gabriel Kimutai; Asirwa, Fredrick Chite; Loehrer, Patrick.

In: Journal of global oncology, Vol. 2018, No. 4, 01.03.2018.

Research output: Contribution to journalArticle

Busakhala, Naftali W. ; Waako, Paul J. ; Strother, Matthew Robert ; Keter, Alfred Kipyegon ; Kigen, Gabriel Kimutai ; Asirwa, Fredrick Chite ; Loehrer, Patrick. / Randomized phase IIA trial of gemcitabine compared with bleomycin plus vincristine for treatment of Kaposi's sarcoma in patients on combination antiretroviral therapy in western Kenya. In: Journal of global oncology. 2018 ; Vol. 2018, No. 4.
@article{3b80e01510b14ec0bda959ae389fdb31,
title = "Randomized phase IIA trial of gemcitabine compared with bleomycin plus vincristine for treatment of Kaposi's sarcoma in patients on combination antiretroviral therapy in western Kenya",
abstract = "Purpose: Kaposi's sarcoma (KS) is a spindle cell tumor resulting from growth dysregulation in the setting of infection with human herpes virus-8 (also called KS herpes virus). Advanced KS is characterized by poor responses to antiretroviral therapy and some of the chemotherapy readily accessible to patients in low-resource areas. Gemcitabine induced partial and complete regression of AIDS-associated KS (AIDS-KS) in 11 of 24 patients in a pilot study. The current study compares the antimetabolite gemcitabine with the standard care bleomycin and vincristine (BV) in the treatment of chemotherapy-na{\"i}ve patients with AIDS-KS in a resource-limited setting. Patients and Methods: Patients with persistent or progressive KS despite treatment with combined antiretroviral therapy were randomly assigned to receive gemcitabine 1,000 mg/m2 or bleomycin 15 IU/ m2 and vincristine 1.4 mg/m2 given twice weekly. The main end point was objective response by bidirectional measurement, adverse events, and quality of life after three cycles of chemotherapy. Results: Of 70 participants enrolled, 36 received gemcitabine and 34 received BV. Complete response was achieved in 12 patients (33.3{\%}) in the gemcitabine arm and six (17.6{\%}) in the BV arm (P = .175). The partial response rate was 52.8{\%} (n = 19) in the gemcitabine arm and 58.8{\%} (n = 20) in the BV arm. Both study arms reported similar neurologic and hematologic adverse events; there was statistically significant baseline to post-treatment improvement in health-related quality-of-life scores. Conclusion: The results of this randomized, phase IIA trial demonstrate gemcitabine activity in chemotherapy-na{\"i}ve patients with AIDS-KS, on the basis of response rates, adverse events, and health-related quality-of-life scores.",
author = "Busakhala, {Naftali W.} and Waako, {Paul J.} and Strother, {Matthew Robert} and Keter, {Alfred Kipyegon} and Kigen, {Gabriel Kimutai} and Asirwa, {Fredrick Chite} and Patrick Loehrer",
year = "2018",
month = "3",
day = "1",
doi = "10.1200/JGO.17.00077",
language = "English (US)",
volume = "2018",
journal = "Journal of global oncology",
issn = "2378-9506",
publisher = "American Society of Clinical Oncology",
number = "4",

}

TY - JOUR

T1 - Randomized phase IIA trial of gemcitabine compared with bleomycin plus vincristine for treatment of Kaposi's sarcoma in patients on combination antiretroviral therapy in western Kenya

AU - Busakhala, Naftali W.

AU - Waako, Paul J.

AU - Strother, Matthew Robert

AU - Keter, Alfred Kipyegon

AU - Kigen, Gabriel Kimutai

AU - Asirwa, Fredrick Chite

AU - Loehrer, Patrick

PY - 2018/3/1

Y1 - 2018/3/1

N2 - Purpose: Kaposi's sarcoma (KS) is a spindle cell tumor resulting from growth dysregulation in the setting of infection with human herpes virus-8 (also called KS herpes virus). Advanced KS is characterized by poor responses to antiretroviral therapy and some of the chemotherapy readily accessible to patients in low-resource areas. Gemcitabine induced partial and complete regression of AIDS-associated KS (AIDS-KS) in 11 of 24 patients in a pilot study. The current study compares the antimetabolite gemcitabine with the standard care bleomycin and vincristine (BV) in the treatment of chemotherapy-naïve patients with AIDS-KS in a resource-limited setting. Patients and Methods: Patients with persistent or progressive KS despite treatment with combined antiretroviral therapy were randomly assigned to receive gemcitabine 1,000 mg/m2 or bleomycin 15 IU/ m2 and vincristine 1.4 mg/m2 given twice weekly. The main end point was objective response by bidirectional measurement, adverse events, and quality of life after three cycles of chemotherapy. Results: Of 70 participants enrolled, 36 received gemcitabine and 34 received BV. Complete response was achieved in 12 patients (33.3%) in the gemcitabine arm and six (17.6%) in the BV arm (P = .175). The partial response rate was 52.8% (n = 19) in the gemcitabine arm and 58.8% (n = 20) in the BV arm. Both study arms reported similar neurologic and hematologic adverse events; there was statistically significant baseline to post-treatment improvement in health-related quality-of-life scores. Conclusion: The results of this randomized, phase IIA trial demonstrate gemcitabine activity in chemotherapy-naïve patients with AIDS-KS, on the basis of response rates, adverse events, and health-related quality-of-life scores.

AB - Purpose: Kaposi's sarcoma (KS) is a spindle cell tumor resulting from growth dysregulation in the setting of infection with human herpes virus-8 (also called KS herpes virus). Advanced KS is characterized by poor responses to antiretroviral therapy and some of the chemotherapy readily accessible to patients in low-resource areas. Gemcitabine induced partial and complete regression of AIDS-associated KS (AIDS-KS) in 11 of 24 patients in a pilot study. The current study compares the antimetabolite gemcitabine with the standard care bleomycin and vincristine (BV) in the treatment of chemotherapy-naïve patients with AIDS-KS in a resource-limited setting. Patients and Methods: Patients with persistent or progressive KS despite treatment with combined antiretroviral therapy were randomly assigned to receive gemcitabine 1,000 mg/m2 or bleomycin 15 IU/ m2 and vincristine 1.4 mg/m2 given twice weekly. The main end point was objective response by bidirectional measurement, adverse events, and quality of life after three cycles of chemotherapy. Results: Of 70 participants enrolled, 36 received gemcitabine and 34 received BV. Complete response was achieved in 12 patients (33.3%) in the gemcitabine arm and six (17.6%) in the BV arm (P = .175). The partial response rate was 52.8% (n = 19) in the gemcitabine arm and 58.8% (n = 20) in the BV arm. Both study arms reported similar neurologic and hematologic adverse events; there was statistically significant baseline to post-treatment improvement in health-related quality-of-life scores. Conclusion: The results of this randomized, phase IIA trial demonstrate gemcitabine activity in chemotherapy-naïve patients with AIDS-KS, on the basis of response rates, adverse events, and health-related quality-of-life scores.

UR - http://www.scopus.com/inward/record.url?scp=85060562217&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85060562217&partnerID=8YFLogxK

U2 - 10.1200/JGO.17.00077

DO - 10.1200/JGO.17.00077

M3 - Article

C2 - 30241150

AN - SCOPUS:85060562217

VL - 2018

JO - Journal of global oncology

JF - Journal of global oncology

SN - 2378-9506

IS - 4

ER -