Direttore UOC di Oncologia Medica

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Direttore UOC di Oncologia Medica This House believes that: Metronomic chemotherapy has an emerging role for early and advanced breast cancer treatment Elisabetta Munzone Discussion Leader. Vito Lorusso Direttore UOC di Oncologia Medica Istituto Oncologico Bari, Italy

Metronomic combinations in early stages key for future trials Conclusions Metronomic chemotherapy is an alternative treatment, especially for palliative indications and for the elderly and/or frail patients that otherwise would not be candidates for MTD chemotherapy Increased attention to patients' quality of life favors the use of active oral treatments. Metronomic combinations in early stages key for future trials

Metronomic combinations in early stages key for future trials Conclusions Metronomic chemotherapy is an alternative treatment, only? for palliative indications and for the elderly and/or frail patients that otherwise would not be candidates for MTD chemotherapy Increased attention to patients' quality of life favors the use of active oral treatments. Metronomic combinations in early stages key for future trials

Is metronomic chemotherapy active? Cyclophosphamide given as last treatment to PS III or elderly/frail patients in which any chemotherapy is contraindicated? Is this “placebo like” treatment to be considered as metronomic chemotherapy? If doctors do not trust in metronomic chemotherapy is mainly due to the fact that most of them have used it only in these cases, when BSC was the real indication.

Metronomic chemotherapy has its dignity! It is a real alternative to MTD chemotherapy when: Patients unfit for MTD Chemotherapy PS 1-2 patients cannot tolerate MTD chemo for other reasons A fully oral home treatment is the best choice for QOL The patient and the doctor agree to start a treatment that is practically devoid of toxicity

Breast cancer

Trials with metronomic chemotherapy in the neoadjuvant setting Elderly women (age > 70 years) or women between 65 and 70 years, unfit for chemotherapy Nat Rev Clin Oncol 2015; 12: 631-44

Trials with metronomic chemotherapy in metastatic breast cancer

Take Home message Metronomic therapy is indicated in breast cancer patients unfit for MTD chemotherapy in neadjuvant setting as well as in advanced stages Not for terminal illness!

Manteinance therapy in Breast Cancer

IBCSG Trial 22-00 (CM Maintenance) Hormone receptor negative (< 10% positive cells by IHC) by locally-determined ER and PgR 1086 patients enrolled Jan 2001 - Dec 2012 RANDOMI ZE * SURGERY Induction Chemotherapy CM Maintenance Chemotherapy (CMM) Stratify Institution Menopausal status Induction regimen 4-6 mos. 12 mos. Induction Chemotherapy Observation (OBS) 4-6 mos. *Any time from start of induction to within 8 weeks after first day of last course of induction 1081 patients in ITT population; Median follow-up 6.9 years

Disease-Free Survival CMM after adjuvant CT reduced the relative risk of recurrence by 20%, and reduced the absolute risk of recurrence by 4.1%

Disease-Free Survival Triple Negative Node Positive and Triple Negative Patients with triple negative and node positive disease experienced the largest benefit: a 7.9% reduction in their absolute risk of recurrence.

Take Home message Metronomic therapy is effective in manteinance chemotherapy in adjuvant setting In particular, it is true fro TNBC

Other neoplasms

My personal point of view Metronomic chemotherapy has demonstrated activity in BC It can obtain disease control for a significant proportion of patients with MBC I usually prescribe metronomic CM or metronomic Vinorelbine plus capecitabine not only in elderly/frail patients, but also in “fit” patients who desire low-toxic treatments or in those who are still in good PS but have already rundown MTD chemotherapy in previous lines. We have also concluded a trial with HEX with exciting preliminary results. 25

Conclusions Metronomic chemotherapy is an alternative treatment: For palliative indications and for the elderly and/or frail patients that otherwise would not be candidates for MTD chemotherapy For fit patients who need/wish less toxic chemotherapy In breast cancer as well as in other neoplasms in all cases when the aim is to preserve quality of life Never to be cosidered as “placebo like” treatment for terminal illness