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Poster display session

3429 - Treatment beyond progression in patients with advanced RCC participating in the Expanded Access Programme (EAP)


10 Sep 2017


Poster display session


Renal Cell Cancer


Enrico Cortesi


Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371


E. Cortesi1, F. Cappuzzo2, L. Galli3, A. Bearz4, S. Pignata5, A. Berruti6, G. Tortora7, D. Tassinari8, S. Panni9, A. Pazzola10, G. Surico11, M. Maio12, L. Latini13, G. Schinzari14, V. Adamo15, E. Ricevuto16, F. Cognetti17, U. de giorgi18, G. Cartenì19, U. Basso20

Author affiliations

  • 1 Scienze Radiologiche, Oncologiche Ed Anatomo-patologiche, Policlinico Umberto I, 161 - Roma/IT
  • 2 Usl6 Di Livorno, USL6 di Livorno, livorno/IT
  • 3 Oncology, Azienda Ospedaliero-Universitaria Pisana Istituto Toscano Tumori, Pisa/IT
  • 4 Cro Aviano, Cro, 33081 - Pordenone/IT
  • 5 Istituto Nazionale Tumori, Istituto Nazionale Tumori, 80131 - Naples/IT
  • 6 Medical Oncology, University of Brescia, Spedali Civili, Brescia/IT
  • 7 Medicine, University of Verona, 37134 - Verona/IT
  • 8 Ausl Della Romagna, Rimini, AUSL della Romagna, Rimini, rimini/IT
  • 9 Istituti Ospitalieri, Cremona, Istituti Ospitalieri, Cremona, cremona/IT
  • 10 Ospedale Civile Ss Annunziata, Sassari, Ospedale Civile SS Annunziata, Sassari, sassari/IT
  • 11 Medical Oncology, Presidio Ospedaliero “Vito Fazzi”, Lecce/IT
  • 12 Azienda Ospedaliera Universitaria Senese - Santa Maria Delle Scotte, Azienda Ospedaliera Universitaria Senese - Santa Maria delle Scotte, 53100 - Siena/IT
  • 13 Ospedale Di Macerata, Macerata, Ospedale di Macerata, Macerata, macerata/IT
  • 14 Medical Oncology, Cattolica University, 00135 - Rome/IT
  • 15 Ospedale Papardo Di Messina, Ospedale Papardo di Messina, messina/IT
  • 16 Oncology, Rete Oncologica ASL1 Abruzzo, L'Aquila/IT
  • 17 Medical Oncology 1, Regina Elena National Cancer Institute, 00144 - Rome/IT
  • 18 Istituto Romagnolo Per Lo Studio E La Cura Dei Tumori, Meldola, Istituto Romagnolo per lo studio e la cura dei Tumori, Meldola, Meldola (FC)/IT
  • 19 Medical Oncology, Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli"-AORN A. Cardarelli, 80131 - Napoli/IT
  • 20 Medical Oncology, Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT


Abstract 3429


Response patterns of immunotherapies differ from those seen with other approved cancer therapies. Therefore, immunotherapy clinical trials generally allow patients (pts) to continue treatment beyond investigator-assessed radiographic progressive disease (PD) as long as there is ongoing clinical benefit, but to date no data have been reported regarding treatment beyond PD in routine clinical practice. Here, we report the analysis about the subgroup of pts treated beyond initial PD in the Italian cohort of nivolumab EAP.


Nivolumab was available upon physician request for pts aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV RCC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks to a maximum of 24 months. Pts included in the analysis had received ≥ 1 dose of nivolumab and were monitored for adverse events (AE) using Common Terminology Criteria for Adverse Events. Patients could continue treatment beyond PD as long as they met the following criteria: investigator-assessed clinical benefit, absence of rapid PD, tolerance of drug, stable performance status and no delay of an imminent intervention to prevent serious complications.


Of 389 nivolumab-treated pts, 231 pts (59%) had PD. Of those, 100 pts (43%) were treated beyond PD. Before being treated beyond PD, the disease control rates (DCR) was 23%, with 5 partial responses (PR) and 18 stable diseases (SD). Post PD, 28 of all pts treated beyond PD achieved a non-conventional benefit, meaning a subsequent tumor reduction or stabilization in tumor lesions. With a median follow-up of 9.2 months (0.1-17.0), 1 year overall survival was 73.5% in pts treated beyond PD and 43.5% for pts who progressed but were not treated beyond PD. The safety profile was consistent to what already observed in the general population.


As already observed in previous studies, these preliminary EAP data seem to confirm that a proportion of pts who continued treatment beyond PD demonstrated sustained reductions or stabilization of tumor burden, with an acceptable safety profile. Further investigation is warranted in order to better define pts who can benefit from treatment beyond PD.

Clinical trial identification

not applicable

Legal entity responsible for the study

Prof. Enrico Cortesi


Bristol-Myers Squibb


All authors have declared no conflicts of interest.

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