Blog

Giovanni Maria Iannantuono: What about cancer patients with poor functional status?

Giovanni Maria Iannantuono/LinkedIn

Jul 6, 2025, 06:20

Giovanni Maria Iannantuono: What about cancer patients with poor functional status?

Giovanni Maria Iannantuono, Medical Oncologist at Fondazione Policlinico Universitario Agostino Gemelli IRCCS, shared a post on LinkedIn:

“Are clinical trials an opportunity reserved only for cancer patients with good functional status? What about those with poorer status?

We reviewed the performance status (PS) eligibility requirements and enrollment characteristics of 283 pivotal clinical trials (CTs) (including 158,510 cancer patients) that led to FDA drug approvals:

Only 25.8% of CTs allowed the enrollment of ECOG PS ≥2 participants;
When eligible, the median proportion of enrolled ECOG PS ≥2 participants was 4.3%;
Early-phase CTs included ECOG PS ≥2 participants more frequently than phase 3 CTs (40.8% vs 20.2%, p = 0.01);
Only 7% of CTs on immunotherapeutic agents allowed the inclusion of ECOG PS ≥2 participants.

FDA has already taken important steps to encourage broadening eligibility criteria.

We truly believe that a real change can happen only through a combined approach from all key stakeholders involved in CTs. How?

Sponsors and IRBs/ECs should carefully select eligibility criteria when writing/reviewing CTs’ protocols (especially for phase 3) to avoid unnecessarily restrictive requirements.
Investigators should be more inclined to enroll ECOG PS ≥2 participants when safe and appropriate.

Read the full paper.

I am deeply grateful to my co-authors for their dedication, expertise, and collaboration:

Center for Cancer Research, National Cancer Institute, National Institute of Health (Bethesda 🇺🇸)
James Gulley, Andrea Apolo Fatima Karzai, Elias Chandran, Elisabetta Xue.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Rome)
Stefano Sganga, Tommaso Giovagnoli, Elena Giudice, Antonio Vitale, Marco Filetti, Pasquale Lombardi, Roberto Rosenfeld, Paola Troisi, Elvira Rapisarda.

A special thanks to my two mentors, without whom this work – and much of my growth – would not have been possible:

Charalampos (Harris) Floudas, thanks for your presence and support. Even though it has been two years since we last met in person, working with you still feels as if we are side by side every day. Your guidance across distance and time zones is invaluable.

Gennaro Daniele, thanks for the trust and encouragement, even in challenging times. Finding a Chief with your vision and humanity is truly rare. Even though our paths will become more distant, I am sure this is only the beginning of a long journey we will continue to share.”

Title: Performance status eligibility requirements and enrollment characteristics in cancer clinical trials leading to US Food and Drug Administration drugs approval (2009–2023)

Authors: Giovanni Maria Iannantuono, Charalampos S. Floudas, Marco Filetti, Tommaso Giovagnoli, Stefano Sganga, Antonio Vitale, Elias Chandran, Pasquale Lombardia, Roberto Rosenfeld, Elena Giudice, Elisabetta Xue, Elvira Rapisarda, Paola Troisi, Andrea B. Apolo, Fatima Karzai, Emilio Bri, James L. Gulley, Gennaro Daniele

Read the Full Article.

Giovanni Maria Iannantuono

#cancer patients Andrea Apolo Fatima Karzai Andrea B Apolo Antonio Vitale cancer Charalampos S. Floudas Elena Giudice Elias Chandran Elisabetta Xue Elvira Rapisarda Emilio Bri Fatima Karzai FDA Gennaro Daniele Giovanni Maria Iannantuono James Gulley James L. Gulley Marco Filetti OncoDaily Oncology Paola Troisi Pasquale Lombardi Pasquale Lombardia Roberto Rosenfeld Stefano Sganga Tommaso Giovagnoli

25 Posts Not To Miss From ESMO GI 2025

Botensilimab and Balstilimab Show Durable Survival in MSS Colorectal Cancer: ESMO GI 2025 Update

Julian McMahon Dies at 56: A Look Back at His Private Cancer Battle and Legendary Acting Career

Vivek Subbiah: It’s Time We Evolve WHO Cancer Classification

ESMO 50th Anniversary: Half a Century of Evidence-Based Cancer Care