Cisplatin and radiation therapy in HIV-positive women with locally advanced cervical cancer in sub-Saharan Africa

A phase II study of the AIDS malignancy consortium

Mark Einstein, Ntokozo Ndlovu, Jeannette Lee, Elizabeth A. Stier, Jeffrey Kotzen, Madhur Garg, Kathleen Whitney, Shelly Y. Lensing, Mariza Tunmer, Webster Kadzatsa, Joel Palefsky, Susan E. Krown

Research output: Contribution to journalArticle

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Abstract

Purpose: To determine the feasibility, safety, and tolerability of concomitant chemoradiotherapy administered at standard doses in HIV-infected women with locally-advanced cervical cancer (LACC) receiving antiretroviral therapy (ART). Patients and methods: Eligible participants had HIV infection and untreated, histologically-confirmed, invasive carcinoma of the uterine cervix, FIGO stages IB2, IIA (if tumor >4 cm), IIB, IIIA, IIIB, or IVA and met standard eligibility criteria. Subjects were prescribed 41.4–45 Gy external beam radiation therapy followed by high dose rate brachytherapy concomitant with up to six weekly doses of cisplatin 40 mg/m2 and were followed for 12 months. Results: Sixty-four women were screened at two sites in sub-Saharan Africa, of whom 40 eligible participants were enrolled, for a screening ratio of 1.60. Of the 38 eligible participants who initiated study treatment, 31 (82%) completed treatment. By the 12-month follow-up visit, 7 women had died of disease and 29 of 31 (94%) returned for follow-up. One-year progression-free survival was 76.3% (95% CI, 59.4–86.9%), and did not significantly differ according to stage at entry (p = 0.581). Participant-reported adherence to ART was high; by 12 months, 93% of participants had an undetectable viral load. The most common grade 3 or 4 adverse event was decreased lymphocyte count that affected all treated participants. Non-hematologic serious adverse events were similar to those observed in women with LACC without HIV infection. Conclusions: The majority of HIV-infected women with LACC can complete concomitant chemoradiotherapy with the same cisplatin dose used in HIV-uninfected women with comparable tolerability and high ART adherence while on treatment.

Original languageEnglish (US)
Pages (from-to)20-25
Number of pages6
JournalGynecologic Oncology
Volume153
Issue number1
DOIs
StatePublished - Apr 1 2019

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Africa South of the Sahara
Uterine Cervical Neoplasms
Cisplatin
Acquired Immunodeficiency Syndrome
Radiotherapy
HIV
Neoplasms
Chemoradiotherapy
HIV Infections
Therapeutics
Brachytherapy
Lymphocyte Count
Viral Load
Cervix Uteri
Disease-Free Survival
Carcinoma
Safety

All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynecology
  • Oncology

Cite this

Einstein, Mark ; Ndlovu, Ntokozo ; Lee, Jeannette ; Stier, Elizabeth A. ; Kotzen, Jeffrey ; Garg, Madhur ; Whitney, Kathleen ; Lensing, Shelly Y. ; Tunmer, Mariza ; Kadzatsa, Webster ; Palefsky, Joel ; Krown, Susan E. / Cisplatin and radiation therapy in HIV-positive women with locally advanced cervical cancer in sub-Saharan Africa : A phase II study of the AIDS malignancy consortium. In: Gynecologic Oncology. 2019 ; Vol. 153, No. 1. pp. 20-25.
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title = "Cisplatin and radiation therapy in HIV-positive women with locally advanced cervical cancer in sub-Saharan Africa: A phase II study of the AIDS malignancy consortium",
abstract = "Purpose: To determine the feasibility, safety, and tolerability of concomitant chemoradiotherapy administered at standard doses in HIV-infected women with locally-advanced cervical cancer (LACC) receiving antiretroviral therapy (ART). Patients and methods: Eligible participants had HIV infection and untreated, histologically-confirmed, invasive carcinoma of the uterine cervix, FIGO stages IB2, IIA (if tumor >4 cm), IIB, IIIA, IIIB, or IVA and met standard eligibility criteria. Subjects were prescribed 41.4–45 Gy external beam radiation therapy followed by high dose rate brachytherapy concomitant with up to six weekly doses of cisplatin 40 mg/m2 and were followed for 12 months. Results: Sixty-four women were screened at two sites in sub-Saharan Africa, of whom 40 eligible participants were enrolled, for a screening ratio of 1.60. Of the 38 eligible participants who initiated study treatment, 31 (82{\%}) completed treatment. By the 12-month follow-up visit, 7 women had died of disease and 29 of 31 (94{\%}) returned for follow-up. One-year progression-free survival was 76.3{\%} (95{\%} CI, 59.4–86.9{\%}), and did not significantly differ according to stage at entry (p = 0.581). Participant-reported adherence to ART was high; by 12 months, 93{\%} of participants had an undetectable viral load. The most common grade 3 or 4 adverse event was decreased lymphocyte count that affected all treated participants. Non-hematologic serious adverse events were similar to those observed in women with LACC without HIV infection. Conclusions: The majority of HIV-infected women with LACC can complete concomitant chemoradiotherapy with the same cisplatin dose used in HIV-uninfected women with comparable tolerability and high ART adherence while on treatment.",
author = "Mark Einstein and Ntokozo Ndlovu and Jeannette Lee and Stier, {Elizabeth A.} and Jeffrey Kotzen and Madhur Garg and Kathleen Whitney and Lensing, {Shelly Y.} and Mariza Tunmer and Webster Kadzatsa and Joel Palefsky and Krown, {Susan E.}",
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Einstein, M, Ndlovu, N, Lee, J, Stier, EA, Kotzen, J, Garg, M, Whitney, K, Lensing, SY, Tunmer, M, Kadzatsa, W, Palefsky, J & Krown, SE 2019, 'Cisplatin and radiation therapy in HIV-positive women with locally advanced cervical cancer in sub-Saharan Africa: A phase II study of the AIDS malignancy consortium', Gynecologic Oncology, vol. 153, no. 1, pp. 20-25. https://doi.org/10.1016/j.ygyno.2019.01.023

Cisplatin and radiation therapy in HIV-positive women with locally advanced cervical cancer in sub-Saharan Africa : A phase II study of the AIDS malignancy consortium. / Einstein, Mark; Ndlovu, Ntokozo; Lee, Jeannette; Stier, Elizabeth A.; Kotzen, Jeffrey; Garg, Madhur; Whitney, Kathleen; Lensing, Shelly Y.; Tunmer, Mariza; Kadzatsa, Webster; Palefsky, Joel; Krown, Susan E.

In: Gynecologic Oncology, Vol. 153, No. 1, 01.04.2019, p. 20-25.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Cisplatin and radiation therapy in HIV-positive women with locally advanced cervical cancer in sub-Saharan Africa

T2 - A phase II study of the AIDS malignancy consortium

AU - Einstein, Mark

AU - Ndlovu, Ntokozo

AU - Lee, Jeannette

AU - Stier, Elizabeth A.

AU - Kotzen, Jeffrey

AU - Garg, Madhur

AU - Whitney, Kathleen

AU - Lensing, Shelly Y.

AU - Tunmer, Mariza

AU - Kadzatsa, Webster

AU - Palefsky, Joel

AU - Krown, Susan E.

PY - 2019/4/1

Y1 - 2019/4/1

N2 - Purpose: To determine the feasibility, safety, and tolerability of concomitant chemoradiotherapy administered at standard doses in HIV-infected women with locally-advanced cervical cancer (LACC) receiving antiretroviral therapy (ART). Patients and methods: Eligible participants had HIV infection and untreated, histologically-confirmed, invasive carcinoma of the uterine cervix, FIGO stages IB2, IIA (if tumor >4 cm), IIB, IIIA, IIIB, or IVA and met standard eligibility criteria. Subjects were prescribed 41.4–45 Gy external beam radiation therapy followed by high dose rate brachytherapy concomitant with up to six weekly doses of cisplatin 40 mg/m2 and were followed for 12 months. Results: Sixty-four women were screened at two sites in sub-Saharan Africa, of whom 40 eligible participants were enrolled, for a screening ratio of 1.60. Of the 38 eligible participants who initiated study treatment, 31 (82%) completed treatment. By the 12-month follow-up visit, 7 women had died of disease and 29 of 31 (94%) returned for follow-up. One-year progression-free survival was 76.3% (95% CI, 59.4–86.9%), and did not significantly differ according to stage at entry (p = 0.581). Participant-reported adherence to ART was high; by 12 months, 93% of participants had an undetectable viral load. The most common grade 3 or 4 adverse event was decreased lymphocyte count that affected all treated participants. Non-hematologic serious adverse events were similar to those observed in women with LACC without HIV infection. Conclusions: The majority of HIV-infected women with LACC can complete concomitant chemoradiotherapy with the same cisplatin dose used in HIV-uninfected women with comparable tolerability and high ART adherence while on treatment.

AB - Purpose: To determine the feasibility, safety, and tolerability of concomitant chemoradiotherapy administered at standard doses in HIV-infected women with locally-advanced cervical cancer (LACC) receiving antiretroviral therapy (ART). Patients and methods: Eligible participants had HIV infection and untreated, histologically-confirmed, invasive carcinoma of the uterine cervix, FIGO stages IB2, IIA (if tumor >4 cm), IIB, IIIA, IIIB, or IVA and met standard eligibility criteria. Subjects were prescribed 41.4–45 Gy external beam radiation therapy followed by high dose rate brachytherapy concomitant with up to six weekly doses of cisplatin 40 mg/m2 and were followed for 12 months. Results: Sixty-four women were screened at two sites in sub-Saharan Africa, of whom 40 eligible participants were enrolled, for a screening ratio of 1.60. Of the 38 eligible participants who initiated study treatment, 31 (82%) completed treatment. By the 12-month follow-up visit, 7 women had died of disease and 29 of 31 (94%) returned for follow-up. One-year progression-free survival was 76.3% (95% CI, 59.4–86.9%), and did not significantly differ according to stage at entry (p = 0.581). Participant-reported adherence to ART was high; by 12 months, 93% of participants had an undetectable viral load. The most common grade 3 or 4 adverse event was decreased lymphocyte count that affected all treated participants. Non-hematologic serious adverse events were similar to those observed in women with LACC without HIV infection. Conclusions: The majority of HIV-infected women with LACC can complete concomitant chemoradiotherapy with the same cisplatin dose used in HIV-uninfected women with comparable tolerability and high ART adherence while on treatment.

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