Contributions
Abstract: PB2173
Type: Publication Only
Background
Approval of new standards of treatment in cancer is usually preceded by phase III clinical trials to demonstrate whether or not a product offers a treatment benefit to a specific population, providing information on safety and efficacy data. There is important selection bias on clinical trials. Strict eligibility criteria could compromise extrapolation of results to the general population.
Aims
Asses if comorbidity by Cumulative Illness rating score for geriatrics (CIRS) score or the possibility of been eligible to participate in clinical trials is associated with dose drug reduction for unsuitable-transplant patients with newly diagnosed multiple myeloma in real setting
Methods
CIRS score, and dose adjustment was assessed retrospectively for transplant-ineligible multiple myeloma patients diagnosed at Hospital Universitario de Araba (Spain). Eligibility criteria of 5 clinical trials: 3 commercial (VISTA, FIRST, ALCIONE) and 2 academic (GEM05MAS65 and GEM10MAS65) were verified for all the patients.
Results
From feb/10 to dec/17, 143 multiple myeloma patients were diagnosed in Hospital Universitario de Araba. 64% of them (92 patients) were transplant-ineligible. Median age was 77 years old, higher than published trials (median age VISTA: 71, FIRST: 73, ALCIONE: 71, GEM05: 73, GEM10: 75). CIRS score identify different prognostic groups in overall survival: CIRS <4: 52.3 months; CIRS 4 to 8: 57 months and CIRS> 8: 13.5 months (p: 0.017). There was a high proportion of patients ineligible for participating in clinical trials: VISTA: 75% FIRST: 70%; ALCIONE 75%; GEM05: 75%; GEM10: 77%. 72% of the patients were treated with bortezomib, melphalan and prednisone scheme, and 28% with bortezomib/dexamethasone +/- ciclophosphamide. In general, tolerance to treatment was good, no deaths attributed to treatment were observed. 47.3% of the patients need to reduce any of the drugs prescribed, and 11% withdrawn treatment due to toxicity. By drugs, melphalan need to be reduce or withdrawn in 57% of patients, bortezomib in 29%, and corticoids in 18% of the patients. Interestingly, we could not observe correlation between the CIRS score and the possibility of been eligible for any of the selected clinical trials. Neither CIRS score nor eligibility for clinical trials was associated with the possibility of reduce of withdrawn chemotherapy.
Conclusion
Clinical trials are excessively restrictive. There is no apparent correlation between the possibility of been eligible for participating in clinical trials, comorbidities and chemotherapy´s adjustment. Eligibility criteria of clinical phase 3 trials compromised extrapolation of security and efficacy of results to real setting patients.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Clinical Trial, Comorbidities, Multiple Myeloma
Abstract: PB2173
Type: Publication Only
Background
Approval of new standards of treatment in cancer is usually preceded by phase III clinical trials to demonstrate whether or not a product offers a treatment benefit to a specific population, providing information on safety and efficacy data. There is important selection bias on clinical trials. Strict eligibility criteria could compromise extrapolation of results to the general population.
Aims
Asses if comorbidity by Cumulative Illness rating score for geriatrics (CIRS) score or the possibility of been eligible to participate in clinical trials is associated with dose drug reduction for unsuitable-transplant patients with newly diagnosed multiple myeloma in real setting
Methods
CIRS score, and dose adjustment was assessed retrospectively for transplant-ineligible multiple myeloma patients diagnosed at Hospital Universitario de Araba (Spain). Eligibility criteria of 5 clinical trials: 3 commercial (VISTA, FIRST, ALCIONE) and 2 academic (GEM05MAS65 and GEM10MAS65) were verified for all the patients.
Results
From feb/10 to dec/17, 143 multiple myeloma patients were diagnosed in Hospital Universitario de Araba. 64% of them (92 patients) were transplant-ineligible. Median age was 77 years old, higher than published trials (median age VISTA: 71, FIRST: 73, ALCIONE: 71, GEM05: 73, GEM10: 75). CIRS score identify different prognostic groups in overall survival: CIRS <4: 52.3 months; CIRS 4 to 8: 57 months and CIRS> 8: 13.5 months (p: 0.017). There was a high proportion of patients ineligible for participating in clinical trials: VISTA: 75% FIRST: 70%; ALCIONE 75%; GEM05: 75%; GEM10: 77%. 72% of the patients were treated with bortezomib, melphalan and prednisone scheme, and 28% with bortezomib/dexamethasone +/- ciclophosphamide. In general, tolerance to treatment was good, no deaths attributed to treatment were observed. 47.3% of the patients need to reduce any of the drugs prescribed, and 11% withdrawn treatment due to toxicity. By drugs, melphalan need to be reduce or withdrawn in 57% of patients, bortezomib in 29%, and corticoids in 18% of the patients. Interestingly, we could not observe correlation between the CIRS score and the possibility of been eligible for any of the selected clinical trials. Neither CIRS score nor eligibility for clinical trials was associated with the possibility of reduce of withdrawn chemotherapy.
Conclusion
Clinical trials are excessively restrictive. There is no apparent correlation between the possibility of been eligible for participating in clinical trials, comorbidities and chemotherapy´s adjustment. Eligibility criteria of clinical phase 3 trials compromised extrapolation of security and efficacy of results to real setting patients.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Clinical Trial, Comorbidities, Multiple Myeloma