Fundacion Instituto Valenciano de Oncología SESIÓN CONTROVERSIAS 4 Quimioterapia Intraperitoneal en Cancer de Ovario Avanzado tras cirugia optima? Moderador: Andres Poveda Fundacion Instituto Valenciano de Oncología Valencia

Dra. Ana Oaknin Benzaquen. • En contra Dr. César Mendiola Fernández. Quimioterapia Intraperitoneal en Cancer de Ovario Avanzado tras cirugia optima? A favor: Dra. Ana Oaknin Benzaquen. Hospital Durán i Reynals (ICO). Barcelona • En contra Dr. César Mendiola Fernández. Hospital Universitario 12 de Octubre. Madrid Conclusión Dr. José Ángel Jiménez Lacave. Hospital Universitario Central de Asturias. Oviedo

A 54 year old woman is diagnosed with Stage IIIA ovarian carcinoma Session # 4 – Stage IIIA Ovarian Cancer: A Role for Intraperitoneal chemotherapy? A 54 year old woman is diagnosed with Stage IIIA ovarian carcinoma Surgery optimal tumor debulking is performed. She has hypercholesterolemia for which she is taking atorvastatin with good control. Otherwise she has no co-morbid illnesses and her performance status pre-op was ECOG 1. Baseline CA-125 was 200 and otherwise laboratory studies are completely normal.

Would you consider for intraperitoneal chemotherapy? Yes? No? Session # 4 – Stage IIIA Ovarian Cancer: A Role for Intraperitoneal Chemotherapy? Would you consider for intraperitoneal chemotherapy? Yes? No?

NCI Clinical Announcement “To bring new information of unusual importance to the attention of clinicians as rapidly as possible” Review of data by an independent panel nominated by investigators and NCI Timed with publication of data

NCI Clinical Announcements Adjuvant therapy, node- breast cancer, 1988 Levamisole & 5FU, Dukes C colon cancer, 1989 Adjvuvant therapy, rectal cancer, 1991

GOG #172 Armstrong et.al. N Engl J Med 2006;354:34-43 Second look Laparotomy (if chosen) BRCA Analysis DNA Banking R A N D O M I Z E Paclitaxel 135 mg/m2/24h Cisplatin 75 mg/m2 q 21 days x 6 Ovarian cancer Optimal (<1cm) Stage III Stratify: Gross residual Planned 2nd look Paclitaxel 135 mg/m2/24h Cisplatin 100 mg/m2 IP D2 Paclitaxel 60 mg/m2 IP D8 q 21 days x 6

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IP Median Survival 66.9 months IV Median Survival = 49.5 months GOG Protocol 172 RR of death 0.71 (95% CI: 0.54, 0.94) P = 0.0076, one-sided log-rank test IP Median Survival 66.9 months IV Median Survival = 49.5 months

Top ten reasons not to give IP chemotherapy Ted Trimble NCI, Bethesda USA 10. I don’t believe the data 9. I don’t know how to give IP chemo (and I don’t want to learn) 8. I don’t like to use cisplatin anymore

Top ten reasons not to give IP chemotherapy 7. There is no standard IP regimen 6. Giving IP chemo takes more time than giving IV chemo 5. It is so easy to give IV carboplatin and a taxane 4. IP chemo has more toxicity than IV chemo (and I don’t want to deal with more toxicity)

Top ten reasons not to give IP chemotherapy 3. There is no big pharmaceutical company encouraging me to use IP 2. IP chemotherapy is an old idea (and I prefer new ideas) 1. IP chemo requires optimal surgical cytoreduction and placement of an IP port

Conclusions The toxicities of IP therapy can be minimized with the use of contemporary supportive care techniques Catheter related problems are related to the experience of surgeons and staff Further studies are required to determine if modulating IP regimens to decrease toxicity and improve tolerability will produce a superior outcome

QT i.p en ca de ovario Comentarios Indicado solo en cirugía optima Efectos 2arios e.s mayores que via iv: Complicaciones cateter (infecciones, bloqueos,.) Dolor abdominal Neuropatía periférica Alteraciones metabólicas Cumplimiento del tto: solo 42% de las pacientes recibieron 6 ciclos; 40% de las pacientes: <4ciclos Resecciones izquierdas: contraindicado??

QT i.p en ca de ovario Temas pendientes/discusion Tipo de cateter Taxol iv 3h en lugar de 24h? Numero de ciclos i.p: 3 o 6? Dosis de CisP ip: 75mg en lugar de 100mg? Brazo control iv actual TCarbo: superior a TCis? Uso de Carbo ip? QoL durante el tratamiento

GCIG Recomendaciones Realizar reuniones cada grupo para: GCIG Recomendaciones Realizar reuniones cada grupo para: - analizar claros y oscuros - analizar problemas reales - favorecer la implementacion en los diferentes paises

CANCER DE OVARIO CONCLUSION La quimioterapia intraperitoneal ha mostrado beneficio en supervivencia en pacientes sin enfermedad residual. La mayor toxicidad respecto a la iv no debe ser obstaculo para seguir investigando como implementarla.