Comparison of generic and specific anxiety in patients treated with apalutamide plus active surveillance vs active surveillance alone for low and intermediate risk prostate cancer.

person Gwenaelle Gravis Department of Medical Oncology, Institut Paoli-Calmettes, Aix-Marseille Universite, CRCM, Marseille, France info_outline Gwenaelle Gravis, Rajae Touzani, Jochen Walz, Guillaume Ploussard, Pierre-Henri Savoie, Matthieu Durand, Gregoire Poinas, Jean-Baptiste Beauval, Romain Mathieu, Youness Ahallal, Sebastien Vincendeau, Mathilde Guerin, Laurys Boudin, Sebastien Crouzet, Naji Salem, Cecile Vicier, Pauline Heux, Patrick Sfumato, Geraldine Pignot, Patricia Marino

Authors person Gwenaelle Gravis Department of Medical Oncology, Institut Paoli-Calmettes, Aix-Marseille Universite, CRCM, Marseille, France info_outline Gwenaelle Gravis, Rajae Touzani, Jochen Walz, Guillaume Ploussard, Pierre-Henri Savoie, Matthieu Durand, Gregoire Poinas, Jean-Baptiste Beauval, Romain Mathieu, Youness Ahallal, Sebastien Vincendeau, Mathilde Guerin, Laurys Boudin, Sebastien Crouzet, Naji Salem, Cecile Vicier, Pauline Heux, Patrick Sfumato, Geraldine Pignot, Patricia Marino Organizations Department of Medical Oncology, Institut Paoli-Calmettes, Aix-Marseille Universite, CRCM, Marseille, France, Institut Paoli-Calmettes, Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques and Sociales de la Santé and Traitement de l’Information Médicale, Marseille, France, Department of Surgical Oncology, Institut Paoli-Calmettes, Marseille, France, Department of Urology, La Croix du Sud Hospital,, Quint Fonsegrives, France, Department of Urology, Sainte Anne Military Teaching Hospital, Toulon, France, Department of Urology, Pasteur University Hospital, Nice, France, Department of Urology, Clinique Beau Soleil, Montpellier, France, Department of Urology, La Croix du Sud Hospital, Quint Fonsegrives, Quint Fonsegrives, France, University of Rennes Hospital Centre, Rennes, France, Department of Urology,CHP saint Gregoire, Saint-Grégoire, France, Department of Medical Oncology, Institut Paoli-Calmettes, Aix-Marseille Université, CRCM, Marseille, France, Department of Oncology, Sainte Anne Military Teaching Hospital, Toulon, France, Urology Department, Edouard Herriot Hospital, University of Lyon, Lyon, France, Department of Radiotherapy, Institut Paoli-Calmettes, Marseille, France, Aix-Marseille Univ, CNRS,INSERM, Institut-Paoli-Calmettes, Department of Medical Oncology, CRCM, Marseille, France, Institut Paoli-Calmettes, Marseille, France, Paoli Calmettes Institute, Department of Clinical Research and Innovation, Statistics and Methodology Unit, Marseille, France Abstract Disclosures Research Funding Pharmaceutical/Biotech Company Janssen Background: Active surveillance (AS) is a standard of care for low-risk prostate cancer (PCa). However, it is not yet clear whether AS may be a source of anxiety in patients (pts) compared to pts receiving treatment. The objective of this study is to compare anxiety in pts receiving apalutamide monotherapy plus AS versus AS alone in pts with low and intermediate-risk PCa. Methods: The study was conducted, in pts enrolled in a multicenter randomized phase 2 trial comparing AS with apalutamide (240 mg) 6 months versus AS alone. Participants completed questionnaires at baseline, 3, 6, and 12 months after diagnosis. We assessed anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) and prostate-specific anxiety using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC). Results: Patients were randomized to AS alone (n = 40) or AS + apalutamide (n = 51). Anxiety questionnaire, response rates, were 98%, 88%, 92%, and 82%, respectively, at baseline, 3 months, 6 months, and 12 months. HADS scores were similar between treatment groups (p > 0.05 at each assessment point) and did not change significantly over time (p > 0.05 for each comparison over time). By analyzing the general MAX-PC anxiety score, we observed that for pts on treatment, anxiety decreased significantly at 3 months compared to baseline (p = 0.01), then remained stable between 3 and 6 months. For pts on AS, anxiety remained stable during the first 3 months and decreased significantly after 3 months (p = 0.018). At the end of treatment (6 months), anxiety increased significantly in pts in the apalutamide arm (p = 0.05) while it remained stable for pts on AS alone. One year after inclusion, the MAX-PC general anxiety levels returned to baseline for both groups of pts. However, for the prostate cancer anxiety subscale, scores decreased significantly from baseline to 12 months in the AS alone group (p = 0.031). Conclusions: Anxiety was reduced in the apalutamide arm after the start of treatment, but this effect was transient and disappeared at the end of treatment. The decrease in anxiety appears to be delayed over time for AS patients, but after a few months, these patients experience a decrease in anxiety levels, suggesting that patients have become accustomed to not being treated. Better detection of PCa specific anxiety was observed, with disease-specific tools such as MAX-PC compared with generic anxiety detection with HADS. Clinical trial information: NCT03088124.

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