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ASCO GU 2021

ASCO GU 2021: Paclitaxel, Ifosfamide & Cisplatin (TIP) as Second-Line Therapy for Germ Cell Tumors: Long-Term Follow-up and Expansion Cohort

(UroToday.com) The combination chemotherapy regimen of paclitaxel, ifosfamide, and cisplatin (TIP) for four cycles was published as a regimen for favorable risk progressive metastatic germ cell tumors in 20051 based on a 46-patient study with 70% achieving a complete response and a 2-year progression-free survival rate of 65%. Favorable risk was classified as only one prior regimen of cisplatin-containing therapy (less than 6 cycles), primary gonadal tumor site, and either complete response or partial response with normal tumor markers that persisted for more than 6 months after first-line chemotherapy. In this presentation, Dr. Jack Gleeson presents the long-term follow-up of the original 46 patients, as well as results from both an expansion cohort of 41 patients that would have met the original study’s inclusion criteria and 17 patients that did not have at least one of the MSKCC favorable risk factors.


As shown below, there are a few notable differences between the primary cohort and the experimental cohort. The primary cohort had a younger median age of 30, had more non-seminoma patients, and the majority of patients had only 1 metastatic site at the time of salvage therapy. The median relapse-free interval for patients in the primary cohort prior to requiring salvage was 1.2 years.  Patients in both cohorts fit into all but the very high IPFSG risk grouping despite qualifying as MSKCC favorable risk.

ASCO_GU_IPFSG_risk.png

The favorable response rate, defined as the number of patients attaining either a complete response or partial response with negative tumor markers, was 80% in the primary cohort and 76% in the exploratory cohort. The 5-year progression free median survival was 70% and 56% in each cohort, respectively. This translated into a 5 year median overall survival of 72% for the primary cohort and 59% for the exploratory cohort.

ASCO_GU_Gleeson.png

Dr. Gleeson concluded that these data continue to support the use of TIP chemotherapy for the management of patients with relapsed germ cell tumors and MSKCC favorable risk criteria. Patients in an exploratory cohort that did not meet MSKCC favorable risk criteria also had better than expected outcomes with TIP therapy. To further delineate optimal initial salvage therapy in germ cell tumors, the TIGER phase 3 trial is ongoing, randomizing patients to TIP versus TI-CE.

Presented by: Jack Gleeson, MD, Memorial Sloan Kettering Cancer Center

Written by: Alok Tewari, MD, PhD, Medical Oncologist at the Dana-Farber Cancer Institute, during the 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium (#GU21), February 11th-February 13th, 2021

References: 

  1. Kondagunta G, Bacik J, Donadio A et al. "Combination of Paclitaxel, Ifosfamide, and Cisplatin Is an Effective Second-Line Therapy for Patients With Relapsed Testicular Germ Cell Tumors." Journal of Clinical Oncology. 2021. 10.1200/JCO.2005.19.638