Gynecological Cancer

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TU_16_3474 - Definitive External Beam Radiation Therapy With Stereotactic Body Radiation Therapy Boost for FIGO Stage IB - IIB Cancer of the Cervix: Minimum 5-Year Disease Control, Toxicity and Quality of Life Outcomes From a Phase 2 Trial

Tuesday, October 23
2:45 PM - 4:15 PM
Location: Innovation Hub, Exhibit Hall 3

Definitive External Beam Radiation Therapy With Stereotactic Body Radiation Therapy Boost for FIGO Stage IB - IIB Cancer of the Cervix: Minimum 5-Year Disease Control, Toxicity and Quality of Life Outcomes From a Phase 2 Trial
C. A. Mantz; 21st Century Oncology, Fort Myers, FL

Purpose/Objective(s): SBRT for gynecologic cancers may offer practical advantages over brachytherapy at similar radiobiologic dosing. Dose-fractionation SBRT schedules may be selected to approximate those of HDR, and SBRT eliminates the needs of optimal applicator placement and sedation. Herein, we report health-related quality of life (HRQOL), toxicity and disease control outcomes of a prospective, phase II trial of SBRT for primary cervical cancers.

Materials/Methods: Eligible patients included those with (1) pathologically confirmed cervical squamous cell carcinoma or adenocarcinoma; (2) FIGO stage IB, IIA or IIB disease; (3) technical or medical contraindication to brachytherapy; and (4) primary GTV < 125 cc following induction therapy. Induction therapy consisted of external beam radiotherapy (EBRT) to a minimum dose of 45.0 Gy encompassing primary tumor and regional pelvic lymphatics. All patients received cisplatin-based chemotherapy concurrent to EBRT. SBRT boost treatment planning then followed, and GTV delineation was aided by co-registration of the boost planning CT set to a pre-EBRT FDG PET/CT scan and post-EBRT MRI. A boost dose of 40.0 Gy was prescribed to the primary tumor and delivered over a 10-day schedule of 5 fractions of 8.0 Gy each. Assessments included (1) disease response was determined pathologically by 3-month post-therapy biopsy and radiographically by biannual PET/CT imaging for 2 years; (2) acute and chronic toxicities were assessed using the National Cancer Institute's CTCAE v3 toxicity scales; and (3) quality-of-life was scored using FACT-G measurements.

Results: Forty-four patients with FIGO stage IB - IIB cervical cancer have been treated since June 2007 and have been followed for a median of 72.0 months and a minimum of 60.0 months. Stage distribution was as follows: 5/44 FIGO stage IB1, 14/44 FIGO stage IB2, 3/44 FIGO stage IIA1, 5/44 FIGO stage IIA2 and 17/44 FIGO stage IIB. Post-SBRT biopsy at 3 months was negative for 41 of 44 patients, or 93.1%, for all patients. At 5 years, estimated local control by combined pathologic and radiographic (i.e., PET SUVmax < 2.5) criteria at the SBRT treatment site is 91.5 % for all patients. No NCI CTCAE grade 3 or greater urinary or bowel toxicities have been observed to date. Post-treatment FACT-G scores were statistically superior compared to pre-treatment assessments for the following studied domains: physical, emotional and functional well-being.

Conclusion: At a minumum followup of 5 years, SBRT offers an effective and well-tolerated boost modality for selected FIGO stage IB - IIB cervix cancer patients otherwise contraindicated for brachytherapy. To our knowledge, this propsective phase 2 study reports the largest cohort of cervical cancer cases treated with curative intent using boost SBRT.

Author Disclosure: C.A. Mantz: None.

Constantine Mantz, MD

21st Century Oncology

Biography:
Constantine A. Mantz MD is currently the Chief Policy Officer for 21st Century Oncology and has formerly served as the company's Chief Medical Officer. He has serves as Principal Investigator for his company's phase II studies of SBRT for prostate and gynecologic cancers and has presented this research at international meetings in addition to serving as a contributing authors to multiple published manuscripts describing novel applications of SBRT. Dr. Mantz has also helped lead his company’s efforts in establishing the first comprehensive bundled payment program for radiation therapy services between a major provider and a major payer and has consulted with Medicare for its current alternative payment efforts.

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TU_16_3474 - Definitive External Beam Radiation Therapy With Stereotactic Body Radiation Therapy Boost for FIGO Stage IB - IIB Cancer of the Cervix: Minimum 5-Year Disease Control, Toxicity and Quality of Life Outcomes From a Phase 2 Trial



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