ESTRO 2022

Session Item

Sunday

May 08

16:55 - 17:55

Room D1

Urology

Co-Chair: Nejla Fourati, Tunisia;

Chair: , Germany

Session Type: Proffered Papers

Track: Clinical

Journey:

17:25 - 17:35

Phase II trial of hypofractionated postoperative radiotherapy in prostate cancer: NCT02192788

Asunción Hervás, Spain

Presentation Number: OC-0608

Abstract

Abstract Title:

Phase II trial of hypofractionated postoperative radiotherapy in prostate cancer: NCT02192788

Authors:

Asunción Hervás¹, Almudena Zapatero², Ana María Carballo³, Marta Barrado⁴, Fernando López-Campos⁵, Carmen Cano⁶, Carmen Martin de Vidales⁷, Aurora Rodríguez⁸, Clara Eito⁹, Antonio Salinas¹⁰, Paula Peleteiro¹¹, Ignacio Visus⁴, Ignacio Rodríguez Melcón¹², Gabriel Vázquez¹³, Antonio Lazo¹⁴, Felipe Couñago¹⁵, Leonardo Guerrero¹⁶, Ana Otero¹⁷, Walter Armando Vasquez¹⁸, Pilar Samper¹⁹, Begoña Caballero²⁰, Gemma Sancho²¹, Rocío Pérez²², Jesús Olivera²³, Angel del Rey²⁴

¹Hospital Universitario Ramón y Cajal, Radiation Oncology, Madrid, Spain; ²Hospital Universitario La Princesa, Radiation Oncology, Madrid, Spain; ³H, Universitario Santiago de Compostela, Radiation Oncology, Santiago de Compostela, Spain; ⁴Complejo Hospitalario de Pamplona, Radiation Oncology, Pamplona, Spain; ⁵H, Universitario Ramón y Cajal, Radiation Oncology, Madrid, Spain; ⁶H. Universitario Torrecárdenas, Radiation Oncology, Almería, Spain; ⁷H. Universitario La Princesa, Radiation Oncology, Madrid, Spain; ⁸H. Ruber Internacional, Radiation Oncology, Madrid, Spain; ⁹Instituto Oncológico IMQ, Radiation Oncology, Bilbao, Spain; ¹⁰H. Universitario Virgen de la Candelaria, Radiation Oncology, Tenerife, Spain; ¹¹H. Universitario Santiago de Compostela, Radiation Oncology, Santiago de Compostela, Spain; ¹²H. Universitario de Gran Canaria Dr. Negrín, Radiation Oncology, Las Palmas de Gran Canaria, Spain; ¹³H. Universitario San Juan de Alicante, Radiation Oncology, Alicante, Spain; ¹⁴H, Universitario Virgen de las Nieves, Radiation Oncology, Granada, Spain; ¹⁵H. Quirón Madrid, Radiation Oncology, Madrid, Spain; ¹⁶H. Quirón La Luz, Radiation Oncology, Madrid, Spain; ¹⁷H. Universitario Virgen de la Victoria, Radiation Oncology, Málaga, Spain; ¹⁸Fundación Jiménez Dñiaz, Radiation Oncology, Madrid, Spain; ¹⁹H. Rey Juan Carlos de Móstoles, Radiation Oncology, Madrid, Spain; ²⁰H. Universitario de Fuenlabrada, Radiation Oncology, Madrid, Spain; ²¹H, Santa Creu i Sant Pau, Radiation Oncology, Barcelona, Spain; ²²H, Carlos Haya, Radiation Oncology, Málaga, Spain; ²³Fundación Jiménez Díaz, Radiation Oncology, Madrid, Spain; ²⁴H, Universitario Ramón y Cajal, Bioinformatics Unit, Madrid, Spain

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Purpose or Objective

HYPORT-ES (ClinicalTrials.gov Identifier: NCT04484038) is a collaborative (URONCOR, GICOR and SEOR) prospective multicenter phase II trial testing hypofractionated postoperative radiotherapy in prostate cancer. We presented the first results of acute gastrointestinal (GI) and genitourinary (GU) toxicity.

Material and Methods

Moderate hypofractionated postoperative radiotherapy (adjuvant and salvage radiotherapy indication according to international guidelines definition) was administered in order to evaluate the feasibility (efficacy and safety) of this scheme. The radiation dose used was 62.5 Gy in 25 fractions of 2.5 Gy/fraction, EQD2= 70 Gy. The inclusion criteria included the presence of unfavourable pathological factors (pT3 and/or positive surgical margins) and/or biochemical failure (PSA ≥ 0.2 and ≤ 2 ng/mL) and/or early salvage (PSA<0.2 ng/mL). Prophylactic nodal irradiation was not allowed. IMRT and IGRT was mandatory. Risk adapted androgen deprivation therapy was permitted. The main outcome measure was acute and late genitourinary (GU) and gastrointestinal (GI) toxicity according to CTCAE. v5 criteria. For acute toxicity we analized patients who had at least 3 months of follow-up from the end of radiotherapy treatment. Secondary outcomes were biochemical control, metastasis-free survival, overall survival and quality of life (EPIC-26, I-PSS and QLQ-30 questionnaires).

Results

From 07/2019 to 09/2021 288 patients from 24 Spanish centers were recruited. Median follow-up was 11 months (range 2-26 months). Median age was 68 years (range 48-83 years), 42% of the patients were pT3 and 62% had positive margins. The indication for postoperative RT was adjuvant in 7% and salvage in 93% of the cases. Median PSA pre-RT was 0.28 ng/ml (0-1.81 ng/ml). 46% of the patients were treated with concomitant androgen deprivation therapy. Acute GU toxicity grade II was observed in 4% of patients, with no cases of acute grade ≥ III GU toxicity; moreover, only 14% of patients developed acute grade II GI toxicity and there were no reported cases of acute GI toxicity ≥ grade III.

Conclusion

Hypofractionated postoperative radiotherapy in prostate cancer is a safe treatment with excellent acute GU and GI toxicity profile. Longer follow-up is needed to evaluated chronic toxicity and oncologic outcomes.