Abstract 95P
Background
Precision oncology aims to improve clinical outcomes personalizing therapies for patients with cancer. Recently, the Italian Ministry of Health (MoH) established a national policy regulating access to free NGS testing and Molecular Tumor Board (MTB) discussion for patients with no effective therapeutical options, PS ECOG 0-2 and life expectancy ≥ 3 months. In this study, we evaluated if the MoH policy is fit-for-purpose to achieve best outcomes for patients.
Methods
We reviewed the records of patients discussed at the European Institute of Oncology MTB between June 2019 and June 2023. We performed survival analysis comparing patients receiving molecularly-matched treatments (MMT) and non-matched treatments (nMMT) in the total population and in cohorts of patients eligible (E) or not eligible (NE) to MTB, based on the MoH criteria (no treatment options defined per previous N of lines - Table 95P). Log-Rank test was used to compare survival distributions.
Results
87 patients received a MMT and 92 received a nMMT among 352 patients discussed at MTB. MMT patients had longer median progression-free survival (mPFS 4.3 months vs 2.9 months; p= .01) and median overall survival (mOS 10.3 months vs 6.3 months, p= .01) compared to nMMT patients. E and NE cohorts included 176 patients each. All the patients in NE cohort did not meet the criterion of previous therapies received. In E cohort, mPFS was 2.4 and 2.8 months (p= .23), and mOS was 6.4 and 6.3 months (p= .14) for patients receiving MMT and nMMT. In NE cohort, mPFS was 5.6 and 3 months (p= .04) and mOS was 12.8 and 6.7 months (p= .08) for patients receiving MMT and nMMT, respectively. Table: 95P
| Tumor type | E | NE | ||||||
| No therapy/lost to FUP | MMT | nMMT | No therapy/lost to FUP | MMT | nMMT | Total | Line of therapy cut-off for inclusion in E cohort (≥) | |
| Anus | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 2 |
| Biliary tract | 7 | 3 | 6 | 15 | 1 | 4 | 36 | 2 |
| Bladder | 1 | 0 | 0 | 1 | 2 | 2 | 6 | 2 |
| Brain | 1 | 1 | 0 | 0 | 0 | 0 | 2 | 2 |
| Breast | 27 | 23 | 8 | 13 | 15 | 9 | 95 | 5 |
| Cervix | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 3 |
| Colorectal | 10 | 4 | 6 | 10 | 2 | 3 | 35 | 4 |
| CUP | 7 | 1 | 4 | 6 | 3 | 7 | 28 | 2 |
| Gastric | 10 | 3 | 4 | 7 | 3 | 2 | 29 | 4 |
| GIST | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 4 |
| HNSCC | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 3 |
| Kidney | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 3 |
| HCC | 0 | 1 | 0 | 0 | 0 | 4 | 5 | 2 |
| Lung | 1 | 10 | 8 | 1 | 0 | 1 | 21 | 3 |
| Oesophagus | 3 | 0 | 2 | 5 | 0 | 1 | 11 | 3 |
| Other, rare | 4 | 1 | 2 | 15 | 5 | 6 | 33 | 2 |
| Ovary | 1 | 0 | 3 | 1 | 0 | 0 | 5 | 3 |
| Pancreas | 2 | 0 | 0 | 9 | 0 | 3 | 14 | 3 |
| Sarcoma | 1 | 0 | 0 | 2 | 0 | 0 | 3 | 3 |
| Skin | 0 | 0 | 1 | 1 | 1 | 1 | 4 | 2 |
| Testis | 0 | 1 | 0 | 3 | 0 | 0 | 4 | 3 |
| Thymus | 0 | 1 | 1 | 1 | 0 | 2 | 5 | 2 |
| Thyroid | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 1 |
| Uterus | 2 | 2 | 0 | 1 | 2 | 1 | 8 | 3 |
| Total | 77 | 53 | 46 | 96 | 34 | 46 | 352 |
FUP: Follow-up. In bold, most frequent tumor types.
Conclusions
Patients receiving MMT had better survival outcomes in the overall population, but mPFS and mOS were longer for patients receiving MMT only in the NE cohort. Our findings suggest MoH criteria may preclude some patients from potentially effective treatments, while current eligible patients may be in too-late lines: so, a revision of the policy could be considered.
Clinical trial identification
This study is approved by IEO Ethical Committee with the reference number UID 3572.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
E. Guerini Rocco: Financial Interests, Personal, Advisory Board: AstraZeneca, Roche, Thermo Fisher, Novartis, GSK; Financial Interests, Personal, Sponsor/Funding: AstraZeneca. D. Trapani: Other, Personal, Other, EMA Healthcare Professional Working Party (HCPWP), member: European Medicines Agency (EMA); Other, Personal, Other, EML Cancer Medicines Working Group (CMWG), member: World Health Organization (WHO); Other, Personal, Other, Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD), Chair: World Health Organization (WHO). C. Criscitiello: Financial Interests, Personal, Invited Speaker: Pfizer, Novartis, Eli Lilly, Roche, Gilead; Financial Interests, Personal, Advisory Board: MSD, Seagen, AstraZeneca, Daiichi Sankyo. G. Curigliano: Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, Daiichi Sankyo, Novartis, Pfizer, Pfizer; Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, Daiichi Sankyo, Lilly, Pfizer, Veracyte, BMS, Merck, Exact Sciences, Celcuity; Financial Interests, Personal, Advisory Board, Advisory Board: Menarini, Gilead; Financial Interests, Personal, Other, Advisory Board: Ellipsis; Financial Interests, Institutional, Research Grant, Investigator Initiated Trial: Merck; Financial Interests, Institutional, Funding, Phase I studies: BMS, Novartis, AstraZeneca, Daiichi Sankyo, Roche, Blueprint Medicine, Kymab, Astellas, Sanofi, Philogen; Financial Interests, Institutional, Invited Speaker, Phase I clinical basket trial: Relay Therapeutics; Non-Financial Interests, Personal, Officer, Italian National Health Council as Advisor for Ministry of Health: Consiglio Superiore di Sanità; Non-Financial Interests, Personal, Advisory Role, Member of the Scientific Council. Patient advocacy association: Europa Donna; Non-Financial Interests, Personal, Advisory Role, Cancer Research Foundation: Fondazione Beretta; Non-Financial Interests, Personal, Member of Board of Directors, No compensation for this role. This a public national company for cancer prevention: Lega Italiana Lotta ai Tumori; Non-Financial Interests, Personal, Officer, Member of the Advisory Council: EUSOMA; Non-Financial Interests, Personal, Officer, ESMO Clinical Practice Guidelines Chair: ESMO; Non-Financial Interests, Personal, Member of Board of Directors, Chair of Clinical Practice Guidelines Committee: ESMO. All other authors have declared no conflicts of interest.