Cyclin-dependent kinase 4/6 inhibition for the treatment of mature teratoma germ cell tumor: Long-term follow-up of a phase II study.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 474-474
Author(s):  
Vivek Narayan ◽  
Wei-Ting Hwang ◽  
Priti Lal ◽  
Mark Alan Rosen ◽  
Maryann Gallagher ◽  
...  
Keyword(s):  
Germ Cell ◽  
Phase Ii ◽  
Mature Teratoma ◽  
Germ Cell Tumors ◽  
Progression Free Survival ◽  
Clinical Event ◽  
Free Survival ◽  
Long Term Follow Up

474 Background: We have previously reported the results of a phase II clinical trial evaluating the safety and efficacy of palbociclib for the treatment of patients with unresectable germ cell tumors, including mature teratoma, teratoma with malignant transformation, and non-teratomatous tumors. In an effort to better assess the efficacy of palbociclib, we now report long-term follow-up of a more homogeneous population of patients with unresectable mature teratoma treated on the phase II clinical trial, with an emphasis on clinically-relevant endpoints for this incurable patient population. Methods: This was a retrospective analysis with long-term follow-up of the patient cohort with mature teratoma treated on the phase II study of palbociclib for the treatment of retinoblastoma protein-expressing germ cell tumors. Patient clinical data was obtained from the medical records and from communication with the enrolled patients and referring medical providers. Major medical events for the treatment of germ cell tumor, including before, during, and after study treatment, were recorded. Clinical events of interest included the initiation of systemic therapy, radiation therapy, surgical debulking, or other invasive procedures. Study endpoints included pre-study and post-study clinical event rates, event-free survival, and radiographic progression-free survival. Results: Long-term follow-up was obtained for 12 patients with mature teratoma. The median pre-study follow-up time was 19.7 months, and the median post-study follow-up time was 38.0 months. The median number of palbociclib treatment cycles was 11. The pre-study clinical event rate was 2.27 events/year (95% CI 1.66 – 3.13), and the post-study event rate was 0.62 events/year (95% CI 0.36 – 1.09). The median progression-free survival was 5.3 months (95% CI 1.8 – 22.6), and the median event-free survival was 16.2 months (95% CI 3.0 – 24.3). Conclusions: The initiation of palbociclib resulted in a clinically-meaningful delay in disease-related major clinical events and radiographic progression. These findings lend further support to the therapeutic activity of CDK4/6 inhibition in this incurable patient population.

Long-term follow-up of chemotherapy-induced remissions in patients with disseminated nonseminomatous germ cell tumors

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5029-5029
Author(s):  
Y. Ehrlich ◽  
M. J. Brames ◽  
S. D. Beck ◽  
R. S. Foster ◽  
L. H. Einhorn
Keyword(s):  
Germ Cell ◽  
Germ Cell Tumors ◽  
Free Survival ◽  
Nonseminomatous Germ Cell Tumor ◽  
Long Term Follow Up ◽  
Prospective Trials ◽  
Lymph Nodes Dissection ◽  
Lost To Follow Up

5029 Background: There is controversy concerning management of patients (pts) with nonseminomatous germ cell tumor (NSGCT) who obtain a chemotherapy-induced complete radiographic (<1cm node diameter) and serologic remission (CR). It has been our policy not to recommend retroperitoneal lymph nodes dissection (RPLND). Proponents of mandatory RPLND cite a 20% to 30% rate of residual microscopic tumor, mostly teratoma, despite achieving CR. Methods: Retrospective analysis of 141 patients with metastatic NSGCT who obtained CR to cisplatin-based first-line chemotherapy. All were observed without RPLND. Included were 78 consecutive pts treated between Jan 1987 and Sept 1994. Additionally included were 63 pts recruited in 4 prospective trials between Oct 1984 and Apr 2005. Seven pts were lost to follow-up (FU) after <2 year. Results: At a median a FU of 15 years (range 3 months to 23.8 years), 12 pts recurred and 4 are dead of disease (DOD). The estimated 15 year recurrence free and disease specific survival was 90% and 97% respectively. The estimated 15 years recurrence free survival for 109 pts with good risk and 32 pts with intermediate or poor risk was 95% and 73% respectively (p = 0.001). Five pts recurred >2 years (range 3–13 years). All 5 are currently disease free. Six pts recurred in the RP and 2 are DOD. Six pts recurred outside the RP. Two of these 6 are DOD. Conclusions: Pts obtaining CR after primary chemotherapy can be safely observed without RPLND. Relapses are rare and potentially curable with further treatment. No significant financial relationships to disclose.

Adjuvant therapy of ovarian germ cell tumors with cisplatin, etoposide, and bleomycin: a trial of the Gynecologic Oncology Group.

1994 ◽  
Vol 12 (4) ◽  
pp. 701-706 ◽  
Author(s):  
S Williams ◽  
J A Blessing ◽  
S Y Liao ◽  
H Ball ◽  
P Hanjani
Keyword(s):  
Germ Cell ◽  
Gynecologic Oncology ◽  
Cell Cancer ◽  
Germ Cell Tumors ◽  
Germ Cell Cancer ◽  
Gynecologic Oncology Group ◽  
Long Term Follow Up ◽  
Acute Myelomonocytic Leukemia

PURPOSE This study was performed to determine the effectiveness of postoperative adjuvant chemotherapy in patients with surgically resected ovarian germ cell tumors. PATIENTS AND METHODS After tumor removal and thorough surgical staging, patients were enrolled on this study and treated with three courses of cisplatin, etoposide, and bleomycin (BEP). Reassessment laparotomy was required of consenting, appropriate patients initially, but became an optional procedure in 1989. RESULTS Of 93 patients assessable on this trial, 89 are continuously free of germ cell cancer. At second-look laparotomy, two other patients were found to have small foci of immature teratoma; both remain clinically free of recurrence. One received subsequent alternate chemotherapy and one did not. Thus, 91 of 93 patients are currently free of germ cell cancer. Follow-up duration ranges from 4.0 to 90.3 months, with 67 patients monitored for longer than 2 years. Acute toxicity was moderate. One patient developed acute myelomonocytic leukemia 22 months after diagnosis. Another patient was noted to have a malignant lymphoma 69 months after protocol treatment. CONCLUSION Three courses of BEP will nearly always prevent recurrence in well-staged patients with completely resected ovarian germ cell tumors and should be given to all such patients. The development of acute leukemia as a complication of treatment is disturbing and mandates careful long-term follow-up, but is unusual and does not alter the risk-to-benefit ratio of treatment.

scholarly journals CTNI-63. PROGNOSTIC FACTORS IN PATIENTS WITH BASAL GANGLIA GERM-CELL TUMORS: A RETROSPECTIVE ANALYSIS OF THE SINGLE CHINESE INSTITUTE EXPERIENCE FROM 2009 TO 2019

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii57-ii57
Author(s):  
Qingjun Hu ◽  
Juan Li ◽  
Mingyao Lai ◽  
Cheng Zhou ◽  
Zhaoming Zhou ◽  
...  
Keyword(s):  
Survival Rate ◽  
Basal Ganglia ◽  
Germ Cell ◽  
Retrospective Analysis ◽  
Surgical Resection ◽  
Germ Cell Tumors ◽  
Progression Free Survival ◽  
Course Of Disease ◽  
Free Survival

Abstract OBJECTIVE To evaluate the clinical factors related to the prognosis of basal ganglia germ cell tumors. METHODS A retrospective analysis of 52 cases of the basal ganglia germ cell tumors treated from January 2009 to January 2019 in the department of oncology of Guangdong Sanjiu Brain Hospital. The median age: 12 years (range: 5–32), The median course of disease: 11.7 months (range: 1–54). Thirteen cases were diagnosed by biopsy and 39 cases were diagnosed by elevated tumor markers. There were 31 patients (59.6%) diagnosed with germinomas and 21 patients (40.4%) with non-germ germ cell tumors. Univariate and multivariate survival analysis was performed. RESULTS To October 15, 2019, the median follow-up time was 30.4 months (range 2–124 months). The 5-year survival rate was 85%, and the 5-year progression-free survival rate was 84%. Multivariate analysis found whether serum AFP was greater than 100mIU / ml, (with HR: 11.441,95% CI: 2.09–47.66, P = 0.005),the degree of surgical resection(with HR 5.323 (1.19–23.812), P = 0.029), PD as the effect of radiotherapy (HR: 16.53, (1.19–23.81), P = 0.001) were independent prognostic factor affecting survival. CONCLUSION The pathological type, degree of surgical resection, and response to initial treatment can all affect survival.

Adult primary extragonadal germ cell tumors: Treatment results and long-term follow-up

2003 ◽  
Vol 41 (1) ◽  
pp. 49-53 ◽  
Author(s):  
Argon Andac ◽  
Basaran Mert ◽  
Bavbek Sevil ◽  
Sakar Burak ◽  
Onat Haluk
Keyword(s):  
Germ Cell ◽  
Germ Cell Tumors ◽  
Treatment Results ◽  
Long Term Follow Up ◽  
Extragonadal Germ Cell Tumors

Thalidomide Based Regimens (TBR) for Relapsed/Refractory Multiple Myeloma Patients: Long Term Follow Up, Unmaintained Remissions and Disease Control after Subsequent Treatments.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4812-4812
Author(s):  
Maria Roussou ◽  
Efstathios Kastritis ◽  
Athanasios Anagnostopoulos ◽  
Evangelos Eleftherakis-Papaiakovou ◽  
Charis Matsouka ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Progression Free Survival ◽  
Free Survival ◽  
Refractory Multiple Myeloma ◽  
Long Term Follow Up ◽  
Group A ◽  
Pulse Dexamethasone ◽  
Group B

Abstract Introduction: The effectiveness of thalidomide based regimens (TBR) in patients with relapsed/refractory multiple myeloma is well established. However, there are still limited data regarding the long term follow up after such regimens and the outcome of patients when they progress and they receive further treatment. In order to answer these questions we evaluated a series of 114 patients with relapsed/refractory multiple myeloma who were treated with TBR. None of these patients had previously received thalidomide, bortezomib or lenalidomide. Patients and Methods: All patients were treated with thalidomide and dexamethasone with or without other oral agents. More specifically 41 patients had received continuous thalidomide and pulse dexamethasone, 25 patients clarithromycin, continuous thalidomide and pulse dexamethasone, 43 patients intermittent thalidomide, pulse dexamethasone and cyclophosphamide and 5 patients continuous thalidomide, pulse dexamethasone and cyclophosphamide. Type of treatment at the time of progression after TBR, response to this treatment and progression free survival were recorded for each patient. Moreover, patients who received novel agents after progression to TBR, were divided into 2 subgroups, according to their resistance to thalidomide. In group A, patients had refractory or progressive myeloma while on TBR or within 2 months after discontinuation of TBR. In group B, myeloma progressed more than 2 months after discontinuation of TBR. Results: Among the 114 patients, 41 had not responded to TBR and 73 (64%) had achieved at least a partial response. The median PFS for all patients was 8 months. As of June 2007, 10 patients remain without progression from 28 to 81 months (median 54 months). Eight patients remain off treatment and without progression for a median of 56 months (range 28–81). Patients who did not respond to or progressed after TBR were analyzed for further treatment and outcome. Thirty eight patients (37%) died before receiving further treatment, 23 patients (23%) received conventional chemotherapy and 41 patients (40%) received continuous thalidomide and dexamethasone +/− clarithromycin or cyclophosphamide (17 patients), bortezomib and dexamethasone (7 patients), melphalan-bortezomib-dexamethasone and intermittent thalidomide (12 patients) or lenalidomide with dexamethasone (5 patients). Among these 41 patients, 24 were classified in group A (thalidomide resistant) and 17 in group B. Overall 17 (41%) achieved at least partial response after retreatment with novel agent-based regimens. A response was observed in 46% of patients in group A and in 35% of patients in group B. The median progression free survival of the 41 patients who received retreatment with novel agents was 9.2 months and the median survival was 17 months. Among the 23 patients who received conventional chemotherapy only five (21%) patients responded and the progression free survival and the median survival were 5.3 and 10.2 months, respectively. Conclusions: After an oral TBR regimen 6 (5%) patients remain without treatment and free of progression for more than 4 years. A significant number of patients who progressed after TBR and who received further treatment which included a novel agent achieved a response, including several patients who were resistant to TBR.

Radiation ±cisplatin for bulky stage IB cervical carcinoma; Long-term follow-up of a GOG trial

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5015-5015
Author(s):  
F. B. Stehman ◽  
S. Ali ◽  
D. G. Gallup ◽  
H. Key
Keyword(s):  
Cervical Carcinoma ◽  
Progression Free Survival ◽  
Free Survival ◽  
Stage Ib ◽  
Long Term Follow Up ◽  
Weekly Cycles ◽  
To Receive ◽  
Weekly Cisplatin

5015 Purpose: To confirm that concurrent cisplatin (CT) with radiation (RT) is associated with improved long-term progression-free survival (PFS), overall survival (OS), and decreased morbidity compared to RT stage IB bulky carcinoma of the cervix, when both groups’ therapy is followed by hysterectomy. Methods: Three hundred seventy-four patients entered this trial. There were 369 evaluable patients; 186 were randomly allocated to receive RT alone and 183 to receive CT+RT. Radiation dosage was 40 Gray (Gy) in 20 fractions followed by a single low dose-rate intracavitary application of 30 Gy to Point A. Chemotherapy consisted of cisplatin 40 mg/M2 every week for up to six weekly cycles. Total extrafascial hysterectomy followed the completion of RT by 3–6 weeks. Results: Preliminary results have been published, at which time there many censored observations and limited follow-up. Patient and tumor characteristics were well-balanced between the regimens. The median patient age was 41.5 years; 81% had squamous tumors; 59% were white. Median follow-up is 101 months. The relative risk for progression was 0.61 favoring CT+RT (95% confidence interval [CI]: 0.43–0.85, p < 0.004). At 72 months 71% of patients receiving CT+RT were predicted to be alive and disease-free when adjusting age and for tumor size compared to 60% of those receiving RT alone. The adjusted death hazard ratio was 0.63 (95% CI: 0.43–0.91, p < 0.015) favoring CT+RT. At 72 months, 78% of CT+RT patients were predicted to be alive compared to 64% of RT patients. An increased rate of early hematologic and gastrointestinal toxicity was seen with CT+RT. There was no detectable difference in the frequency of late adverse events. Conclusion: Concurrent weekly cisplatin with RT significantly improves long term PFS and OS when compared to RT alone. Serious late effects were not increased. The inclusion of hysterectomy has been discontinued on the basis of another trial. Pending further trials, weekly cisplatin with radiation is the standard against which other regimens must be compared. Key Words: Cervical carcinoma, chemoradiotherapy. No significant financial relationships to disclose.

Cetuximab and chemotherapy in the treatment of patients with initially “nonresectable” colorectal (CRC) liver metastases: Long-term follow-up of the CELIM trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3538-3538 ◽  
Author(s):  
Gunnar Folprecht ◽  
Thomas Gruenberger ◽  
Wolf Bechstein ◽  
Hans-Rudolf Raab ◽  
Juergen Weitz ◽  
...  
Keyword(s):  
Liver Metastases ◽  
Tumor Response ◽  
Progression Free Survival ◽  
R0 Resection ◽  
Term Survival ◽  
Free Survival ◽  
Long Term Follow Up ◽  
Clinical Trial Information

3538 Background: CRC liver metastases can be resected after downsizing with intensive chemotherapy schedules, with a strong correlation between the response and resection rates. Cetuximab plus chemotherapy has been shown to increase the rates of tumor response and resection of liver metastases. (Van Cutsem et al, JCO 2011). Methods: Patients (pts) with technically non-resectable and/or with > 4 liver metastases were randomized to treatment with FOLFOX/cetuximab (arm A) or FOLFIRI/cetuximab (arm B) and evaluated regarding resectability every 2 months. Resection was offered to all patients who became resectable during the study. K-ras and b-raf status were retrospectively evaluated. Data on tumor response and resection were reported earlier (Folprecht et al, Lancet Oncol 2010). Overall and progression free survival were analyzed in December 2012. Results: Between Dec 2004 and March 2008, 56 pts were randomized to arm A, 55 to arm B. For the current analysis, 109 pts were evaluable for overall survival (OS), and 106 patients for PFS. The median OS was 35.7 [95% CI: 27.2-44.2] months (arm A: 35.8 [28.1-43.6], arm B: 29.0 [16.0-41.9], HR 1.03 [0.66-1.61], p=0.9). The median PFS was 10.8 [9.3-12.2] months (Arm A: 11.2 [7.2-15.3], Arm B: 10.5 [8.9-12.2], HR 1.18 [0.79-1.74], p=0.4). Patients with R0 resection had a better OS (median: 53.9 [35.9-71.9] mo) than patients without R0 resection (27.3 [21.1-33.4] mo, p=0.002) and a better PFS (median 15.4 [11.4-19.5] and 8.9 [6.7-11.1] mo in R0 resected and not R0 resected pts, p<0.001). The 5 year survival in R0 resected patients is 46.2% [29.5-62.9%]. Conclusions: This study confirmed a favourable long term survival of patients with initially “nonresectable” CRC liver metastases treated in a multidisciplinary approach of neoadjuvant chemotherapy with cetuximab and subsequent metastasectomy in pts who became resectable. Clinical trial information: NCT00153998. [Table: see text]

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