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Gynecol Oncol. 2019 Apr;153(1):20-25. doi: 10.1016/j.ygyno.2019.01.023. Epub 2019 Feb 15.

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.

Author information

1
Department of Obstetrics, Gynecology, & Women's Health, Rutgers New Jersey Medical School, Newark, NJ, United States of America. Electronic address: mark.einstein@rutgers.edu.
2
College of Health Sciences, University of Zimbabwe Harare, Zimbabwe.
3
Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, United States of America. Electronic address: JYLee@uams.edu.
4
Department of Obstetrics and Gynecology, Boston University School of Medicine, Boston, MA, United States of America. Electronic address: elstier@bu.edu.
5
Department of Radiation Oncology, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: Jeffrey.Kotzen@wits.ac.za.
6
Department of Radiation Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Yeshiva University, Bronx, NY, United States of America. Electronic address: MGARG@montefiore.org.
7
Department of Pathology, Montefiore Medical Center, Albert Einstein College of Medicine, Yeshiva University, Bronx, NY, United States of America. Electronic address: kwhitney@montefiore.org.
8
Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, United States of America. Electronic address: SYLensing@uams.edu.
9
Radiation Oncology Wits Donald Gordon Medical Centre, Johannesburg, South Africa. Electronic address: mariza.tunmer@wits.ac.za.
10
Department Radiotherapy and Oncology, College of Health Science University of Zimbabwe, Harare, Zimbabwe.
11
Department of Medicine, University of California, San Francisco, San Francisco, CA, United States of America. Electronic address: Joel.Palefsky@ucsf.edu.
12
AIDS Malignancy Consortium, New York, NY, United States of America. Electronic address: krowns@mskcc.org.

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.

PMID:
30773222
PMCID:
PMC6430646
[Available on 2020-04-01]
DOI:
10.1016/j.ygyno.2019.01.023
[Indexed for MEDLINE]

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