In a study of cancer patients considering whether they should participate in phase I clinical trials, a high percentage were willing to participate after discussions with clinical staff, but nearly half thought that their tumors would shrink, which is much higher than what is realistically achieved.
In a study of cancer patients considering whether they should participate in phase I clinical trials, a high percentage were willing to participate after discussions with clinical staff, but nearly half thought that their tumors would shrink, which is much higher than what is realistically achieved. Published early online in CANCER, a peer-reviewed journal of the American Cancer Society, the findings demonstrate the challenges facing patients and healthcare professionals during their interactions in phase I studies.
Phase I trials are designed to assess the potential of investigational treatments that have never before been tested in humans. The trials, which are often restricted to patients with advanced disease that has not responded to standard therapy, start with conservatively low doses of a drug or other therapy and escalate until a recommended dose for a phase II trial is established. Typical response rates of phase I cancer trials range from four percent to 20 percent, and enrolled patients survive for a median of six months.
Ethically, healthcare professionals must ensure that patients are well informed about the likelihood of risks and benefits of phase I trials, and it is important to determine how effectively they’re relaying such information. Led by Udai Banerji, MD, PhD, a UK team at The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research explored patients’ motivations for considering phase I trials and assessed their expectations both before and after they consulted with clinicians.
For the study, 396 patients who were considering participation in a phase I clinical trial completed questionnaires prior to being seen, and 301 completed an abbreviated follow-up questionnaire after consultation with clinicians.
When asked about the potential personal benefit of participating, 43 percent predicted tumor shrinkage in the initial questionnaire. After consultation, this increased to 47 percent. Thus current methods of communication did not lessen patients’ pre-consultation expectations of benefit. Overall, patients were keen to consider trials, with 72 percent of pre- and 84 percent of post-clinic patients willing to enroll.
“There is a positive message in this, which is that 84 percent of patients are willing to participate in phase I oncology studies after a discussion with clinical and nursing staff who lay out the conservative estimates of benefit and requirements of hospital visits. This is good for current and future patients and cancer medicine in general,” said Dr. Banerji. He added, “the high percentage of patients expecting their tumors to shrink was a sobering finding. This creates a challenge for healthcare professionals to manage expectations but to do so without being patronizing or dismissing human hope.” The results also point to the need to improve patient information and consent forms.
Additional Information:
Full Citation: “A study of the motivations and expectations of patients seen in phase I oncology clinics.” Saoirse O. Dolly, Eleftheria Kalaitzaki, Martina Puglisi, Sarah Stimpson, Janet Hanwell, Sonia Serrano Fandos, Sarah Stapleton, Thushara Ansari, Clare Peckitt, Stan Kaye, Juanita Lopez, Timothy A. Yap, Winette van der Graaf, Johann de Bono, and Udai Banerji. CANCER; Published Online: September 26, 2016 (DOI: 10.1002/cncr.30235).
Link to study: http://onlinelibrary.wiley.com/doi/10.1002/cncr.30235/abstract
Author Contact: Elaine Lipscombe at Elaine.Lipscombe@icr.ac.uk or 020 8661 3993.
About the Journal
CANCER is a peer-reviewed publication of the American Cancer Society integrating scientific information from worldwide sources for all oncologic specialties. The objective of CANCER is to provide an interdisciplinary forum for the exchange of information among oncologic disciplines concerned with the etiology, course, and treatment of human cancer. CANCER is published on behalf of the American Cancer Society by Wiley and can be accessed online at http://wileyonlinelibrary.com/journal/cancer.
Follow us on Twitter @JournalCancer and Facebook https://www.facebook.com/ACSJournals
About Wiley
Wiley is a global provider of knowledge and knowledge-enabled services that improve outcomes in areas of research, professional practice and education. Through the Research segment, the Company provides digital and print scientific, technical, medical, and scholarly journals, reference works, books, database services, and advertising. The Professional Development segment provides digital and print books, online assessment and training services, and test prep and certification. In Education, Wiley provides education solutions including online program management services for higher education institutions and course management tools for instructors and students, as well as print and digital content. The Company's website can be accessed at www.wiley.com.
Dawn Peters-
+1 781-388-8408
sciencenewsroom@wiley.com