Clinical benefit of systemic therapies for recurrent ovarian cancer—ESMO-MCBS scores

Abstract

Background Licensed systemic treatment options for platinum-sensitive recurrent ovarian cancer are platinum-based chemotherapy and maintenance treatment with bevacizumab and poly (ADP-ribose) polymerase inhibitors. For platinum-resistant disease, several non-platinum options are available. We aimed to assess the clinical benefit of these treatments according to the European Society of Medical Oncology (ESMO)-Magnitude of Clinical Benefit Scale (MCBS). Materials and methods A PubMed search was carried out including all studies evaluating systemic treatment of recurrent epithelial ovarian cancer, from 1990 onwards. Randomised trials with an adequate comparator and design showing a statistically significant benefit of the study arm were independently scored by two blinded observers using the ESMO-MCBS. Results A total of 1127 papers were identified, out of which 61 reported results of randomised trials of sufficient quality. Nineteen trials showed statistically significant results and the studied treatments were graded according to ESMO-MCBS. Only three treatments showed substantial benefit (score of 4 on a scale of 1-5) according to the ESMO-MCBS: platinum-based chemotherapy with paclitaxel in the platinum-sensitive setting and the addition of bevacizumab to chemotherapy in the platinum-resistant setting. The WEE1 inhibitor adavosertib (not licensed) also scores a 4, based on a recent small phase II study. Assessment of quality-of-life data and toxicity using the ESMO-MCBS showed to be complex, which should be taken into account in using this score for clinical decision making. Conclusion Only a few licensed systemic therapies for recurrent ovarian cancer show substantial clinical benefit based on ESMO-MCBS scores. Trials demonstrating overall survival benefit are sparse.

Quimioterapia adyuvante en cáncer epitelial de ovario en estadios avanzados

“…ciclofosfamida al de ciclofosfamida -doxorrubicinacisplatino, de este al de ciclofosfamida-platino y por último al de taxano-platino, de acuerdo con la respuesta clínica a estos esquema. 11 Por último, un ensayo clínico en 2000, el estudio GOG 111, aleatoriza, a 38 pacientes con tumores de gran volumen para recibir paclitaxel-cisplatino versus ciclofosfamida-cisplatino, reportando que la eficacia terapéutica del primer grupo tuvo una tasa de respuesta global significativamente mejor (73% frente a 60%), así como mayor tasa de respuesta clínica completa, aunque la frecuencia de respuesta patológica completa fue parecida en los dos grupos. El tratado con paclitaxel logró una mejoría significativa en la sobrevida libre de progresión (SSP, 18 meses frente a 13) y la sobrevida general (SG 38 frente a 24 meses).…”

“…El riesgo de progresión fue 32% más bajo entre las tratadas con el régimen de paclitaxel y el riesgo de muerte fue 39% más bajo. 11 Además un ensayo entre grupos europeos-canadienses (OV-10), informaron una tasa de respuesta clínica superior en el tratado con paclitaxel (59% versus 45%), con una reducción de 25% en la tasa de mortalidad 12 , lo que confirmaba los hallazgos previos. Después la investigación GOG 158 realizó un estudio de no inferioridad donde compara el carboplatino en reemplazo del cisplatino, encontrando que el riesgo de progresión era equivalente en los dos grupos (RR=0,88; IC 0-1-03) y la toxicidad mayor con paclitaxel y cisplatino 13 , resultado confirmado por el grupo para cáncer de ovario de Arbeitsgemeninschaft Gynäkologische Onkologie (AGO) que obtuvieron resultados clínicos similares.…”

Evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for adjuvant radiotherapy in breast cancer

“…As part of an ongoing continual quality improvement process, the ESMO-MCBS has been subjected to evaluation in various disease settings to identify shortcomings that might be addressed in future iterations of the scale. 6 , 7 , 8 , 9 , 10 The detailed evaluation of the application of the ESMO-MCBS in hematological malignancies identified six shortcomings that needed to be addressed to improve the applicability of the scale for hematological malignancies. Subsequently ESMO and the European Hematology Association have developed a version of the scale specifically tailored for hematologic malignancies that has now been robustly validated.…”