Can patients (pts.) with refractory germ cell tumors (GCT) be cured after progression following high dose chemotherapy (HDCT) with tandem transplant? Results with paclitaxel + gemcitabine

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4588-4588
Author(s):  
D. A. Lewis ◽  
M. J. Brames ◽  
L. H. Einhorn
Keyword(s):  
Germ Cell ◽  
Objective Response ◽  
Germ Cell Tumors ◽  
Disease Free Survival ◽  
High Dose Chemotherapy ◽  
Salvage Chemotherapy ◽  
High Dose ◽  
Cell Transplant ◽  
Indiana University

4588 Background: A previously published ECOG study of paclitaxel (P) plus gemcitabine (G) in refractory germ cell tumors achieved a 21% response rate (6 of 28 pts.) (JCO 20:1859, 2002). Two patients are continuously NED for 4+ years. Neither had prior HDCT. High dose salvage chemotherapy with carboplatin + etoposide and peripheral blood stem cell transplant has curative potential. Subsequent chemotherapy after progression following HDCT has only rarely achieved durable remission. We have retrospectively reviewed pts. treated at Indiana University with P + G after failure to cure with initial cisplatin combination chemotherapy and salvage HDCT (± other salvage regimens). Methods: 184 patients received salvage HDCT from February 1996 to December 2004. After further progression, 33 pts. were treated with P 100 mg/M2 over 1 hour and G 1000 mg/M2 over 30 minutes days 1, 8, and 15 every 4 weeks for a maximum of 6 courses. Pts. were ineligible if they received prior P or G. 26 pts. received P + G as 3rd line, 6 as 4th line and 1 as 5th line chemotherapy. Results: Toxicity was primarily myelosuppression and neuropathy, as previously described with P + G (JCO 20:1859, 2002). There was no treatment related mortality. 10 of 33 pts. achieved objective response including 4 partial (2 to 6 months duration) and 6 complete responses (C.R.). 4 of the 6 C.R.s are continuously NED with P + G alone at 14+, 34+, 44+, and 45+ months from start of P + G. One additional C.R. is currently NED 54+ months after P + G, with 2 subsequent resections of carcinoma. Conclusions: Long-term disease free survival and potential cure is possible with P + G in this patient population after progression following HDCT. [Table: see text]

Phase II Study of Paclitaxel Plus Gemcitabine Salvage Chemotherapy for Germ Cell Tumors After Progression Following High-Dose Chemotherapy With Tandem Transplant

2007 ◽  
Vol 25 (5) ◽  
pp. 513-516 ◽  
Author(s):  
Lawrence H. Einhorn ◽  
Mary J. Brames ◽  
Beth Juliar ◽  
Stephen D. Williams
Keyword(s):  
Patient Population ◽  
Objective Response ◽  
Germ Cell Tumors ◽  
Disease Free Survival ◽  
High Dose Chemotherapy ◽  
Salvage Chemotherapy ◽  
High Dose ◽  
Term Survival ◽  
Disease Free

Purpose To determine long-term survival and potential cure with salvage chemotherapy with paclitaxel plus gemcitabine after progression after both cisplatin combination chemotherapy and subsequent high-dose chemotherapy with tandem transplantation. Patients and Methods One hundred eighty-four patients received salvage high-dose chemotherapy at Indiana University (Indianapolis, IN) from February 1996 to December 2004. After further evidence of progressive disease, 32 patients were subsequently treated with paclitaxel 100 mg/n2 over 1 hour plus gemcitabine 1,000 mg/m2 over 30 minutes, days 1, 8, and 15 every 4 weeks for a maximum of six courses. This is a retrospective review of this patient population. Patients were evaluated for response, duration of response, and survival. Patients were ineligible if they received prior paclitaxel or gemcitabine. Results Ten (31%) of 32 patients achieved objective response, including four partial remissions (2- to 6-month duration) and six complete responses (CRs). Four of these six CRs (12.5% of total patient population) are continuously disease free (NED) with paclitaxel plus gemcitabine alone (no postchemotherapy surgery) at more than 20, 40, 44, and 57 months from start of paclitaxel plus gemcitabine, respectively. One additional CR is currently NED more than 63 months after paclitaxel plus gemcitabine with two subsequent resections of carcinoma. Conclusion Long-term disease-free survival is possible with paclitaxel plus gemcitabine in this patient population that progressed after high-dose chemotherapy, and had not received prior paclitaxel or gemcitabine.

Results of Treatment After Relapse From High-Dose Chemotherapy in Germ Cell Tumors

2000 ◽  
Vol 18 (6) ◽  
pp. 1181-1186 ◽  
Author(s):  
Pierluigi Porcu ◽  
Sumeet Bhatia ◽  
Matt Sharma ◽  
Lawrence H. Einhorn
Keyword(s):  
Germ Cell ◽  
Response Rate ◽  
Objective Response ◽  
Germ Cell Tumors ◽  
High Dose Chemotherapy ◽  
Salvage Treatment ◽  
High Dose ◽  
Term Survival ◽  
Platinum Based Chemotherapy

PURPOSE: To identify therapy-related or patient-related characteristics that predict response and long-term survival after failure of high-dose chemotherapy (HDCT) for germ cell tumors (GCT). PATIENTS AND METHODS: Between 1986 and 1997, 101 GCT patients relapsed after high-dose carboplatin and etoposide (VP-16) at Indiana University (Indianapolis, IN). Median time to relapse was 10 months (range, 1 to 17 months). HDCT was the first salvage treatment in 29 patients and second or later salvage treatment in 72 patients. RESULTS: Fifty-four of 101 patients received post-HDCT treatment. Of these, 47 received chemotherapy, alone (n = 35) or in combination with surgery (n = 12). Seven patients underwent surgery alone. There were only 12 objective responses (three complete and nine partial responses) for 66 chemotherapy regimens given to 47 patients, for an overall response rate of 18.2%. Fifteen patients received platinum-based chemotherapy, with only one objective response. Chemotherapy was discontinued in 17% of cases because of toxicity. A longer interval between HDCT and post-HDCT treatment was the only variable that was associated with response. Five patients (4.9%) are disease-free at 30, 53, 57, 85, and 93 months after relapse. Of these, three responded to oral VP-16 and underwent resection of residual mediastinal, retroperitoneal, and inguinal cancer, respectively. One had resection of residual mediastinal yolk sac tumor, followed by oral VP-16. One relapsed with teratoma and received thoracoabdominal resection without chemotherapy. CONCLUSION: Patients who experience disease progression after HDCT often receive further chemotherapy and/or surgery. Chemotherapy resulted in a response rate of less than 20%, with only three complete responses. All of the long-term survivors (4.9%) had surgery as a component of their post-HDCT regimen.

Salvage chemotherapy with high dose carboplatin + etoposide (HDCE) and peripheral blood stem cell transplant (PBSCT) in patients with germ cell tumors (GCT)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4549-4549 ◽  
Author(s):  
L. H. Einhorn ◽  
S. Williams ◽  
R. Abonour
Keyword(s):  
Germ Cell ◽  
Germ Cell Tumors ◽  
Salvage Chemotherapy ◽  
Late Relapse ◽  
High Dose ◽  
Cell Transplant ◽  
Cure Rate ◽  
Indiana University ◽  
Prior Therapy ◽  
Hematopoietic Recovery

4549 Background: We began studies with HDCE for patients (pts.) with recurrent GCTs 20 years ago. During the past decade, better supportive care and use of PBSCT allowed outpatient therapy and more rapid hematopoietic recovery between the 2 courses of HDCE. Methods: Retrospective review of 184 consecutive pts. treated with HDCE at Indiana University from 2–96 to 12–04. Late relapse (> 2 years from prior therapy) and primary mediastinal non-seminomatous germ cell tumor pts. were not offered HDCE. Cytoreduction with 0–2 courses of vinblastine + ifosfamide + cisplatin preceded HDCE. C dosage was 700 mg/M2 × 3 and E 750 mg/M2 × 3. A second course was given after hematologic recovery. Results: Toxicity was as previously described (JCO 18:3346, 2000). There were 3 drug- related mortalities. An additional 3 patients developed AML (2 fatal), and 1 glioma following CNS XRT for metastases. 11 pts. did not receive second course (8 due to progression or HDCE mortality). Median time to second course HDCE was 28 days (range 20 to 42). 116 of 184 pts. are alive and continuously (cont) NED (63%) with median followup 42 months (range 11 to 118). 113 (97%) of these are 12+ months NED. 5 additional pts. are currently NED with further therapy. Results are tabulated below. Conclusions: HDCE has a high cure rate with acceptable toxicity as salvage therapy for GCT pts. [Table: see text] [Table: see text]

Long-Term Survival After High-Dose Salvage Chemotherapy for Germ Cell Malignancies With Adverse Prognostic Variables

2003 ◽  
Vol 21 (22) ◽  
pp. 4100-4104 ◽  
Author(s):  
Daniel A. Vaena ◽  
Rafat Abonour ◽  
Lawrence H. Einhorn
Keyword(s):  
Germ Cell ◽  
Poor Prognosis ◽  
Germ Cell Tumors ◽  
High Dose Chemotherapy ◽  
Salvage Chemotherapy ◽  
High Dose ◽  
Prognostic Variables ◽  
Term Survival ◽  
Risk Patients ◽  
Platinum Refractory

Purpose: Independent prognostic variables for patients undergoing high-dose chemotherapy (HDCT) as salvage modality for germ cell tumors (GCT) were previously described, and a score was created. Patients with more than 2 points had a poor prognosis. However, these data were from patients treated from 1984 to 1993, and most received a single HDCT course. In this study, we evaluated outcomes at Indiana University and determined the applicability of the Beyer score to contemporary poor-risk patients. Patients and Methods: We performed a retrospective analysis of patients who received salvage HDCT between 1988 and 2001 and had at least one of the following characteristics: platinum-refractory or absolutely platinum-refractory GCT, primary mediastinal nonseminomatous GCT (PMNSGCT), human chorionic gonadotropin (HCG) ≥ 1,000 mU/mL or alpha-fetoprotein (AFP) ≥ 1,000 ng/mL before HDCT. Primary end points were overall and 2-year failure-free survival (FFS). Results: Eighty patients were identified. Fifty-six were platinum refractory, 23 had a Beyer score greater than 2, and 13 had PMNSGCT. Fifty-six patients received two HDCT courses. HDCT included carboplatin and etoposide. Forty-three patients received HDCT as first salvage modality. Median overall survival was 14.7 months. The 2-year FFS was 32%. No relapses have occurred after 2 years from HDCT. Patients with greater than 2 points in the Beyer score, platinum-refractory patients, and patients with HCG ≥ 1,000 mU/mL, AFP ≥ 1,000 ng/mL, and PMNSGCT had 2-year FFS of 30%, 37%, 26%, 18%, and 0%, respectively. Conclusion: Results with PMNSGCT remained poor. However, other patients with poor prognosis should not be denied an attempt at curative salvage HDCT.

Residual tumor resections (RTR) in patients with germ cell tumors (GCT) after salvage chemotherapy.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4601-4601
Author(s):  
Christian Winter ◽  
Cigdem Bingoel ◽  
Ralf Witthuhn ◽  
Patrick De Geeter ◽  
Peter Albers
Keyword(s):  
Germ Cell ◽  
Tumor Progression ◽  
Relapse Rate ◽  
Cell Cancer ◽  
Disease Free Survival ◽  
Residual Tumor ◽  
Salvage Chemotherapy ◽  
High Dose ◽  
Term Survival

4601 Background: Residual tumor resections (RTR) after salvage chemotherapy are of utmost importance due to a much higher rate of vital carcinoma in the residual tumor. A complete RTR may lead to an improved long term survival of such patients (pts). Methods: A retrospective analysis was performed in 197 pts who underwent 209 RTRs in 2 referral centers (2003-2011) with identical surgical technique (2 surgeons). The RTR database was queried for pts who received salvage chemotherapy (conventional salvage chemotherapy (CCT) or high-dose salvage chemotherapy (HDCT)) and a subsequent RTR. Results: Sixty (29%) of all RTRs were performed after salvage chemotherapy. In 31 pts (52%) and 29 pts (48%) a CCT and HDCT was used as salvage regimen, respectively.Vital cancer was found in 48% and 45% of pts with CCT and HDCT. Respectively, vital cancer consisted of germ cell cancer and malignant transformed teratoma in 61% and 39% of the cases. In contrast, the percentage of vital cancer in pts after 1st-line treatment was 30% (p= 0.0365).This comparatively high rate is due to a 55% rate of intermediate/poor prognosis pts in the whole group of 209 RTRs. To date we have evaluated the oncological outcome in 171 of 197 pts with a median follow-up of 23 months (1-227). In 142 pts no relapse was observed, whereas in 29 pts a GCT relapse occured (17%), 7 (4.6%) of all evaluated pts had an “in-field”-relapse. 7 pts died due to tumor progression. The relapse rate in pts with RTR after salvage regime was significantly higher compared to RTR pts after primary chemotherapy (37% vs. 13%, p= 0.0008). The „in-field“-relapse rate in pts with RTR after salvage was only in 3.9%, 2 pts died due to tumor progression. Conclusions: Every second pts with RTR after salvage chemotherapy showed vital cancer in the residual tumor. The relapse rate in pts with RTR after salvage chemotherapy was significantly higher compared to RTR pts after first-line chemotherapy (p=0.0008) but the “infield” relapse rate was similar. A complete resection of all residual lesions after salvage chemotherapy is necessary to potentially improve the long-term disease-free survival. This is especially true for pts with malignant transformed teratoma and restricted options for repeated salvage chemotherapy.

Survival and toxicity outcomes in patients age 40 or older with relapsed metastatic germ cell tumors (mGCT) treated with high-dose chemotherapy (HDCT) and autologous peripheral-blood stem cell transplant (PBSCT).

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 522-522
Author(s):  
Nabil Adra ◽  
Costantine Albany ◽  
Rafat Abonour ◽  
Mohammad Issam Abu Zaid ◽  
Dannillo Pereira ◽  
...  
Keyword(s):  
Salvage Therapy ◽  
Germ Cell Tumors ◽  
Progression Free Survival ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Cell Transplant ◽  
Indiana University ◽  
Free Survival ◽  
Kaplan Meier

522 Background: HDCT plus PBSCT is effective salvage therapy for relapsed mGCT but has potential toxicity which can be more pronounced in older patients. We report survival and toxicity outcomes in pts with relapsed mGCT age ≥ 40 at time of HDCT. Methods: 440 consecutive pts with relapsed mGCT were treated with HDCT and PBSCT with tandem cycles at Indiana University (IU) between 2004-2017 per our previous reported regimen (N Engl J Med 2007; 357: 340-8). Kaplan-Meier methods were used for progression free survival (PFS) analysis. Results: 110 pts were age ≥ 40 while 330 pts were age < 40. Among pts age ≥ 40, median AFP was 6.6 (range, 1-2,709) and median hCG was 5.3 (range, 1-42, 453). Of the 110 pts age ≥ 40, 75 had complete remission without relapse during a median follow-up of 23 months. There were 3 treatment-related deaths. Conclusions: HDCT plus PBSCT is safe and effective salvage therapy in pts age ≥ 40 with relapsed mGCT. [Table: see text]

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