Tandem Cycle High-Dose Melphalan and Busulfan/Cyclophosphamide Followed by Maintenance Interferon Alpha-2 (IF) with or without Thalidomide (Thal) Is Associated with High Complete and Very Good Partial Response Rates, Improved Progression-Free, and Overall Survival.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3089-3089
Author(s):  
George Somlo ◽  
Dajun Qian ◽  
Firoozeh Sahebi ◽  
Neil Martin Kogut ◽  
Roberto Rodriguez ◽  
...  
Keyword(s):  
Overall Survival ◽  
Radiation Therapy ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Concomitant Administration ◽  
Entire Group ◽  
High Dose ◽  
Day Range ◽  
High Dose Melphalan ◽  
To Receive

Abstract Tandem cycle high-dose melphalan (Mel) followed by Mel +/− total body radiation therapy improves progression-free (PFS) and overall survival (OS) in comparison to single cycle Mel, but is associated with 3% treatment-related mortality (TRM). We tested a new tandem regimen (THDCT) followed by maintenance therapy in order to lower TRM, while enhancing efficacy. Between 5/94 and 8/04, 114 patients (pts) were enrolled on 2 sequential studies. First, pts received Mel 150 mg/m2 [cycle 1 (C1)], oral busulfan (bu 16 mg/kg; 46 pts), and cyclophosphamide 120 mg/kg (Cy; C2); the next cohort received the same THDCT but bu was given intravenously (i.v. 12.8 mg/kg; 68 pts). All pts were to receive maintenance IF 3 million units/m2 given subcutaneously, 3 times/week. Pts participating on the 2nd study were to receive thal together with IF provided that they were not in CR at 6 months post-THDCT. Peripheral blood progenitor cell mobilization consisted of G-CSF 10 microgram/kg to procure 4 x 106 CD34+ cells/kg without (first 46 pts) or with Cy 1.5 g/m2 (last 68 pts). Pts ≤65 years, with responsive or stable MM, with <40% marrow involvement, with a creatinine clearance of 70 cc/min and Karnofsky performance status of 70% were enrolled. Median age was 52 years (range: 29–65); 70% of pts were diagnosed with stage III MM, and 4 pts presented with plasma cell leukemia; 40% received prior radiation therapy. Pts received a median of 1(1–3) induction chemotherapy regimens; the median time from diagnosis to THDCT was 8 months (range: 2–73); 89% of pts received both C-s at a median of 76 days (range, 29–134). Among the first 46 pts (treated with oral bu) there were 7 cases of veno-occlusive disease (VOD): 3 were fatal, resulting in TRM of 7%. There were 8 cases of VOD in the 68 pt cohort treated with i.v. bu, one of whom died of multi-organ failure/sepsis (TRM:1.5%). Eighty nine percent of pts tolerated at least 1 million units/m2 of IF 2–3 times/week. Of pts receiving concomitant IF and thal (median dose of thal: 100 mg/day[range, 50–400]), only 7 pts tolerated both (median: 4 months; range: 1.6–18 months), 3 of whom converted to CR. At best response 44% pts were in CR and 12% achieved 90% reduction (very good partial remission (VGPR). For the entire group, 3-year PFS is 50% (95% CI, 40–59%) and OS is 71% (95%CI, 61–78%). Three-year PFS is 66% (95% CI 52–76%) vs. 29% (95% CI 16–42%) and OS is 87% (95% CI 76–93%) vs. 49% (95% CI 35–63%) favoring pts in CR and VGPR vs. all others. THDCT with Mel and i.v. bu /Cy and maintenance IF can be given safely, and may provide an alternative regimen to tandem Mel. Concomitant administration of IF and thal is not feasible. Thal should be used either in sequence or in lieu of IF as maintenance.

Abbreviated Course of Radiation Therapy in Older Patients With Glioblastoma Multiforme: A Prospective Randomized Clinical Trial

2004 ◽  
Vol 22 (9) ◽  
pp. 1583-1588 ◽  
Author(s):  
W. Roa ◽  
P.M.A. Brasher ◽  
G. Bauman ◽  
M. Anthes ◽  
E. Bruera ◽  
...  
Keyword(s):  
Overall Survival ◽  
Radiation Therapy ◽  
Glioblastoma Multiforme ◽  
Older Patients ◽  
Treatment Time ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Wilcoxon Test ◽  
Rank Test ◽  
Survival Times

Purpose To prospectively compare standard radiation therapy (RT) with an abbreviated course of RT in older patients with glioblastoma multiforme (GBM). Patients and Methods One hundred patients with GBM, age 60 years or older, were randomly assigned after surgery to receive either standard RT (60 Gy in 30 fractions over 6 weeks) or a shorter course of RT (40 Gy in 15 fractions over 3 weeks). The primary end point was overall survival. The secondary end points were proportionate survival at 6 months, health-related quality of life (HRQoL), and corticosteroid requirement. HRQoL was assessed using the Karnofsky performance status (KPS) and Functional Assessment of Cancer Therapy-Brain (FACT-Br). Results All patients had died at the time of analysis. Overall survival times measured from randomization were similar at 5.1 months for standard RT versus 5.6 months for the shorter course (log-rank test, P = .57). The survival probabilities at 6 months were also similar at 44.7% for standard RT versus 41.7% for the shorter course (lower-bound 95% CI, −13.7). KPS scores varied markedly but were not significantly different between the two groups (Wilcoxon test, P = .63). Low completion rates of the FACT-Br (45%) precluded meaningful comparisons between the two groups. Of patients completing RT as planned, 49% of patients (standard RT) versus 23% required an increase in posttreatment corticosteroid dosage (χ2 test, P = .02). Conclusion There is no difference in survival between patients receiving standard RT or short-course RT. In view of the similar KPS scores, decreased increment in corticosteroid requirement, and reduced treatment time, the abbreviated course of RT seems to be a reasonable treatment option for older patients with GBM.

High-Dose Melphalan and Stem Cell Transplantation for Patients with AL Amyloidosis and Cardiac Involvement

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2043-2043
Author(s):  
Saulius Girnius ◽  
David C Seldin ◽  
Karen Quillen ◽  
Nancy T Andrea ◽  
John Mark Sloan ◽  
...  
Keyword(s):  
Overall Survival ◽  
Cardiac Involvement ◽  
Troponin I ◽  
Performance Status ◽  
Stage I ◽  
Stage Iii ◽  
High Dose ◽  
Al Amyloidosis ◽  
Cardiac Biomarker ◽  
High Dose Melphalan

Abstract Abstract 2043 Treatment of AL amyloidosis (AL) with high dose melphalan and autologous stem cell transplant (HDM/SCT) results in a high rate of durable complete hematologic responses associated with clinical responses and improvement in survival. However, patients with cardiac involvement are at increased risk of treatment-related mortality (TRM). Recently, cardiac biomarkers, B-type natriuretic peptide (BNP) and troponins, have been used to predict survival for AL amyloidosis patients, including those undergoing treatment with HDM/SCT. Here we report on treatment-related mortality (TRM), overall survival, and time to next treatment (progression) and hematologic responses in patients with AL amyloidosis and cardiac involvement, stratified by cardiac biomarker stage, treated with HDM/SCT. Eligibility for HDM/SCT was based upon strict functional and clinical criteria rather than upon staging based upon biomarkers, and required a Zubrod performance status <2, NYHA heart failure class < III, left ventricular ejection fraction (LVEF) >40%, and adequate cardiopulmonary reserve at a stair climb. Cardiopulmonary exercise testing was also used for some patients. Cardiac involvement was determined by electrocardiographic and echocardiographic abnormalities, as defined by Consensus Opinion of the 10th Symposium on Amyloid and Amyloidosis. A cardiac risk assessment or “cardiac staging” system incorporating biomarkers was used, with patients assigned to stage I (normal biomarkers, BNP < 100 pg/mL and troponin I < 0.1 ng/mL), II (one elevated biomarker) or III (both biomarkers elevated). Between 1/2008 and 10/2010, 35 patients with AL amyloidosis and cardiac involvement were treated with HDM/SCT. The median age was 58 years (range, 41–72). There were 17 males (49%) and 29 (83%) with lambda clonal plasma cell dyscrasia. All but one patient had multi-organ involvement and 80% (n=28) had renal involvement. Eleven percent (n=4) patients had cardiac biomarker stage I disease, 31% (n=11) had stage II disease, and 57% (n=20) had stage III disease. The median troponin I level was 0.121 ng/mL (range, 0.006 – 0.523), and the median BNP was 224 pg/mL (range, 18–923). The median interventricular septal thickness was 13 mm (range, 9–18) and the median LVEF was 60% (range, 40–70). Peripheral blood stem cells were mobilized using G-CSF alone at 10–16 m/kg/day for 3–4 days. The total dose of melphalan, administered over two consecutive days, depending on age, severity of cardiac disease and performance status. Forty % (n=14) received 200 mg/m2 HDM and 60% (n=21) received 140 mg/m2 HDM. TRM, defined as deaths within 100 days of SCT, occurred in 3 patients (9%), all cardiac stage III (3/20, 15% of the stage III patients); patients with cardiac stage I or II did not have any TRM. This compares to a TRM of 3% (n=1/30) in patients without cardiac involvement who were treated with HDM/SCT during the same time period (Fisher's exact test, p=0.6177). There were two additional deaths during the first year after HDM/SCT, one with cardiac stage II disease and one with stage III disease. Three-year overall survival for combined Stage I and II disease was 93%, for Stage III it was 76%, and for the cohort without cardiac involvement it was 96% (p=0.08). Three-year progression free survival for combined Stage I and II disease was 69%, for Stage III it was 45%, and without cardiac involvement it was 69% (p=0.0424). Median overall survival and progression free survivals have not been reached, with a median follow-up for 21 months. By intention-to-treat analysis, 23% (n=8) of patients achieved a hematologic complete response (CR) and 46% (n=16) a partial response (PR) at 1 year following HDM/SCT. Thirty % (n=11) required additional treatment by one year following HDM/SCT. While the cardiac biomarker stage III group clearly encompasses patients at high risk of early mortality from disease and complications of treatment, for patients that meet functional criteria for HDM/SCT, this therapeutic modality may offer the potential for effective treatment for selected stage III patients. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Preventing Discontinuation of Radiation Therapy: Predictive Factors to Improve Patient Selection for Palliative Treatment

2017 ◽  
Vol 13 (9) ◽  
pp. e782-e791 ◽  
Author(s):  
Lindsay L. Puckett ◽  
Eric Luitweiler ◽  
Louis Potters ◽  
Sewit Teckie
Keyword(s):  
Overall Survival ◽  
Radiation Therapy ◽  
Bone Metastasis ◽  
Brain Metastases ◽  
Patient Selection ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Factors Associated ◽  
Patients With Cancer ◽  
Selection For

Purpose: Approximately one third of patients with cancer require palliative radiation therapy (PRT), yet no guidelines exist for optimal patient selection. We have observed that many patients who begin PRT do not complete their prescribed treatment. Our study sought to identify factors associated with discontinuation of PRT, assess for a relationship with survival, and inform patient selection. Methods: We performed an institutional review board–approved retrospective analysis of patients with cancer treated in a multicenter radiation oncology department in 2014. Of 297 patients who began PRT, 60 discontinued and 237 completed treatment. Primary end points included discontinuation and overall survival. Results: Patient factors were analyzed for association with discontinuation of PRT and overall survival, respectively, using logistic regression and Cox proportional regression models. Factors associated with discontinuation were low Karnofsky performance status (KPS) score, high number of fractions prescribed, and treatment site other than bone metastasis. The odds of discontinuing PRT decreased by approximately 52% for every 10-point increase in KPS score (odds ratio, 0.48; 95% CI, 0.36 to 0.63; P < .001). Factors associated with shorter survival included discontinuation of PRT, low KPS score, community practice location, multiple comorbidities, and treatment of brain metastases. Patients who discontinued treatment were more likely to die than patients who completed treatment, independent of other factors (hazard ratio, 3.67; 95% CI, 2.41 to 5.61; P < .001). Conclusion: Patients with low KPS scores, long treatment courses, and those treated to sites other than bone metastasis were significantly more likely to discontinue treatment. Discontinuation was predictive for poor survival. Pretreatment evaluation of KPS, comorbidities, and brain metastases can help guide appropriate patient selection for PRT.

Clinical utility of the systemic immune-inflammation index for predicting survival in esophageal squamous cell carcinoma after radical radiotherapy

2021 ◽  
Author(s):  
Yuan Wang ◽  
Jiahua Lyu ◽  
Hongyuan Jia ◽  
Long Liang ◽  
Ling Xiao ◽  
...  
Keyword(s):  
Overall Survival ◽  
Squamous Cell Carcinoma ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Clinical Utility ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Entire Group ◽  
Immune Inflammation

Aim: To explore the clinical utility of the systemic immune-inflammation index (SII) for predicting the prognosis of esophageal squamous cell carcinoma (ESCC). Patients & methods: After calculating the SII in 180 patients with ESCC, the relationship between SII values and the pre-/post-radiotherapy SII ratio and overall survival was determined. Results: The median overall survival was 649 days for the entire group and 909 and 466 days for the high and low pre-/post-radiotherapy SII ratio groups, respectively. Multivariate analysis identified Karnofsky performance status (p = 0.045), lymphatic metastasis (p = 0.032), mid-radiotherapy SII (p < 0.001) and pre-/post-radiotherapy SII ratio (p = 0.003) as independent prognostic factors. Conclusion: The pre-/post-radiotherapy SII ratio and mid-radiotherapy SII are potentially effective markers for predicting ESCC prognosis.

METIS: A phase 3 study of radiosurgery with TTFields for 1-10 brain metastases from NSCLC.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS9106-TPS9106
Author(s):  
Minesh P. Mehta ◽  
Vinai Gondi ◽  
Paul D. Brown
Keyword(s):  
Overall Survival ◽  
Brain Metastases ◽  
Karnofsky Performance Status ◽  
Systemic Disease ◽  
Performance Status ◽  
Rank Test ◽  
In Vivo Models ◽  
To Receive ◽  
The Brain

TPS9106 Background: Tumor Treating Fields (TTFields) are non-invasive regional anti-mitotic treatment modality, based on low intensity alternating electric fields. Efficacy of TTFields in non-small cell lung cancer (NSCLC) has been demonstrated in multiple in vitro and in vivo models, and in a phase I/II clinical study. TTFields treatment to the brain was shown to be safe and to extend overall survival in newly-diagnosed glioblastoma patients. Methods: 270 patients with 1-10 brain metastases (BM) from NSCLC will be randomized in a ratio of 1:1 to receive stereotactic radio surgery (SRS) followed by either TTFields or supportive care alone. Patients are followed-up every two months until 2nd cerebral progression. Patients in the control arm may cross over to receive TTFields at the time of 2st cerebral progression. Objectives: To test the efficacy, safety and neurocognitive outcomes of TTFields in this patient population. Endpoints: Time to 1st cerebral progression based on the RANO-BM Criteria or neurological death (primary); time to neurocognitive failure based on the following tests: HVLT, COWAT and TMT; overall survival; radiological response rate; quality of life; adverse events severity and frequency (secondary). Main eligibility criteria: Karnofsky performance status (KPS) of 70 or above, 1 inoperable or 2-10 brain lesions amenable to SRS, optimal standard therapy for the extracranial disease, no brain-directed therapy, no signs of significantly increased intracranial pressure, no electronic implantable devices in the brain. Treatment: Continuous TTFields at 150 kHz for at least 18 hours per day will be applied to the brain within 7 days of SRS. The treatment system is a portable medical device allowing normal daily activities. The device delivers TTFields to the brain using 4 Transducer Arrays, which may be covered by a wig or a hat for cosmetic reasons. Patients will receive the best standard of care for their systemic disease. Statistical Considerations: This is a prospective, randomized, multicenter study for 270 patients. The sample size was calculated using a log-rank test (based on Lakatos 1988 and 2002) and has 80% power at a two sided alpha of 0.05 to detect a hazard ratio of 0.57. Clinical trial information: NCT02831959.

scholarly journals The impact of pulmonary function in patients undergoing autologous stem cell transplantation

2021 ◽  
Author(s):  
Jesus Duque-Afonso ◽  
Sophie Ewald ◽  
Gabriele Ihorst ◽  
Miguel Waterhouse ◽  
Tim Strüessmann ◽  
...  
Keyword(s):  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
High Dose ◽  
Toxic Substances ◽  
Hematopoietic Stem ◽  
High Dose Melphalan ◽  
The Impact

High-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (auto-HSCT) is an established therapy for patients with hematological malignancies. The age of patients undergoing auto-HSCT, and therefore the co-morbidities, has increased during the last decades. However, the assessment of organ dysfunction prior auto-HSCT has not been well undertaken. Therefore, we analyzed retrospectively the association of clinical factors, lung and cardiac function with outcome and complications after conditioning with BEAM (BCNU/carmustin, etoposide, cytarabine, melphalan) and high-dose melphalan of patients undergoing auto-HSCT. In this study, we included 629 patients treated with auto-HSCT (334 conditioned with BEAM and 295 with high-dose melphalan) at our institution between 2007 and 2017. The median follow-up for patients conditioned with BEAM was 52 months (range:0.2-152) and with high-dose melphalan 50 months (range:0.5-149). In the multivariate analysis, we identified progressive disease, CO-diffusion capacity corrected for hemoglobin (DLCOcSB)&lt;60% of predicted, Karnofsky performance status (KPS)≤80%, HCT-CI score≥4 and age&gt;70 years to be associated with decreased overall survival (OS) in patients treated with BEAM. Similarly, DLCOcSB&lt;60% of predicted, HCT-CI score ≥4 and age&gt;60 years were identified in patients treated with high-dose melphalan. Abnormalities in DLCOcSB&lt;60% of predicted were associated with chemotherapy with lung toxic substances, mediastinal radiotherapy, KPS≤80%, current/previous smoking and treatment at the intensive care unit. Patients with decreased DLCOcSB&lt;60% of predicted had more frequently non-relapse mortality, including pulmonary cause of death. In summary, we have identified DLCOcSB&lt;60% of predicted as an independent risk factor associated with decreased OS in patients conditioned with BEAM and high-dose melphalan prior auto-HSCT.

scholarly journals Clinical Efficacy of HiPorfin Photodynamic Therapy for Advanced Obstructive Esophageal Cancer

2020 ◽  
Vol 19 ◽  
pp. 153303382093033
Author(s):  
Ruifang Zeng ◽  
Chen Liu ◽  
Libo Li ◽  
Xiaojun Cai ◽  
Run Chen ◽  
...  
Keyword(s):  
Overall Survival ◽  
Esophageal Cancer ◽  
Radiation Therapy ◽  
Photodynamic Therapy ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Advanced Esophageal Cancer ◽  
Karnofsky Performance Status Score ◽  
Status Score ◽  
Performance Status Score

Objective: To explore the clinical efficacy of HiPorfin photodynamic therapy for advanced esophageal cancer and evaluate its impact on survival. Methods: Retrospective analysis of 32 patients with advanced obstructive esophageal cancer at our institution from September 2013 to December 2016. HiPorfin was infused as the photosensitizer at a dose of 5 mg/kg, and after 48 hours, 630-nm laser irradiation was subsequently performed through an optical fiber that passed through the biopsy channel of a flexible endoscope. Results: The effectiveness rate was 78.1% (25/32), and the significant efficacy rate was 56.3% (18/32). The dysphagia score decreased from 3.43 ± 0.73 to 1.79 ± 0.53 ( P < .05). There was no grade 3 or more toxicity. The median overall survival was estimated to be 16 months. Univariate analysis showed higher overall survival with a Karnofsky Performance Status score ≥80 compared with a Karnofsky Performance Status score <80 (hazard ratio: 2.626; 95% CI: 1.091-6.322; P = .024). Overall survival was higher in patients who had received radiation therapy than in patients who did not receive radiation therapy (hazard ratio: 3.574; 95% CI: 1.501-8.510; P = .002). Conclusion: Photodynamic therapy is an effective method for advanced esophageal cancer. The side effects are mild, and the short-term effect is good, especially in the relief of dysphagia. Photodynamic therapy can prolong the survival of patients with advanced esophageal cancer, and the Karnofsky Performance Status score and previous radiation therapy have a significant effect on the overall survival.

scholarly journals Scleromyxedema: role of high-dose melphalan with autologous stem cell transplantation

Blood ◽  
2006 ◽  
Vol 107 (2) ◽  
pp. 463-466 ◽  
Author(s):  
Michele L. Donato ◽  
Adrienne M. Feasel ◽  
Donna M. Weber ◽  
Victor G. Prieto ◽  
Sergio A. Giralt ◽  
...  
Keyword(s):  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Autologous Transplantation ◽  
High Dose ◽  
Pulmonary Manifestations ◽  
High Dose Melphalan ◽  
Lichen Myxedematosus

AbstractScleromyxedema, the most severe manifestation of the spectrum of lichen myxedematosus, is characterized by cutaneous mucinosis, extracutaneous manifestations, and a monoclonal gammopathy. Seven of 8 patients evaluated at our center were treated with high-dose melphalan (180 mg/m2 intravenously) and autologous peripheral blood stem cell transplantation, with marked improvement of gastrointestinal, central nervous system, pulmonary manifestations, and Karnofsky performance status. Five patients obtained a cutaneous complete remission and 2 patients had partial remissions. Three patients with slight progression in the skin at 12, 8, and 4 months after treatment received a second cycle of high-dose melphalan and had further symptomatic improvement. The lichen myxedematosus–scleromyxedema spectrum appears to be a continuum that requires the presence of a serum paraprotein and differs in severity of skin lesions, extracutaneous manifestations, and performance status. High-dose melphalan followed by autologous transplantation appears effective for improving the symptoms and systemic manifestations of scleromyxedema.

scholarly journals 312 Female sex independently predicts adjuvant immunotherapeutic benefit from CTLA4 immune checkpoint inhibition

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A339-A339
Author(s):  
Ahmad Tarhini ◽  
Ni Kang ◽  
Sandra Lee ◽  
F Stephen Hodi ◽  
Gary Cohen ◽  
...  
Keyword(s):  
Overall Survival ◽  
Treatment Efficacy ◽  
Significant Interaction ◽  
Cox Regression ◽  
Performance Status ◽  
Phase Iii ◽  
High Dose ◽  
List Type ◽  
Female Sex ◽  
Interaction Term

BackgroundSex differences in tumor immunity and response to immunotherapy were shown in murine models and descriptive analyses from recent clinical trials. Female sex hormones have been implicated in melanoma development and response to systemic therapy. We hypothesized a gender difference in response to adjuvant immunotherapy with ipilimumab (3 or 10 mg/kg; ipi3 or ipi10) versus high dose IFNα (HDI) as tested in the E1609 trial.MethodsE1609 demonstrated significant overall survival (OS) benefit with ipi3 versus HDI.1 We investigated treatment efficacy between ipi and HDI in the subgroups by sex (female, male), age (< 55 or ≥55), stage at study entry (IIIB, IIIC, M1a/1b), ECOG performance status (PS 0, 1), ulceration (yes, no), primary tumor (known, unknown), number of lymph nodes involved (0, 1, 2–3, 4+). Forest plots were created to compare OS and RFS with ipi3 vs. HDI and ipi10 vs. HDI using the concurrently randomized ITT populations. For the estimated HRs, 95% confidence intervals were created for all subgroups.ResultsThe subgroups of female, stage IIIC, PS=1, ulcerated, in-transit without lymph node involvement demonstrated significant improvement in overall survival (OS) and/or relapse free survival (RFS) with ipi3 versus HDI as summarized in table 1. Female sex was significant for both OS and RFS and was further explored. In investigating RFS with ipi3 versus HDI, a multivariate Cox regression model including sex, treatment and interaction term of sex*treatment, indicated a significant interaction between sex and treatment (P = 0.026). Including sex, PS (0 vs. 1), age (<55 vs. 55+), ulceration (yes vs. no), stage (IIIB, IIIC, M1a, M1b), treatment and interaction term of sex*treatment, indicated a significant interaction between sex and treatment (P = 0.024). While similar trends were seen, no significant interactions between sex and treatment effect were found in the OS multivariate analysis or in the comparison of ipi10 versus HDI. When exploring age, in the univariate analyses in the ipi3 versus HDI comparison older women appeared to drive most of the difference (age ≥55: OS, P=0.02 and RFS, P=0.08; differences non-significant for women <55). Table 1.Abstract 312 Table 1Treatment efficacy between ipi3 and HDI by subgroupConclusionsFemale sex was independently associated with RFS adjuvant immunotherapeutic benefit from ipi3, supporting a potentially important role for female related factors in the immune response against melanoma, and these warrant further investigation.Trial RegistrationNCT01274338Ethics ApprovalThe study protocol was approved by the institutional review board (IRB) of each participating institution and conducted in accordance with Good Clinical Practice guidelines as defined by the International Conference on Harmonisation. This study was monitored by the ECOG-ACRIN DataSafety Monitoring Committee and the NCI.ConsentAll patients provided IRB-approved written informed consent.ReferenceTarhini AA, Lee SJ, Hodi FS, Rao UNM, Cohen GI, Hamid O, Hutchins LF, Sosman JA, Kluger HM, Eroglu Z, Koon HB, Lawrence DP, Kendra KL, Minor DR, Lee CB, Albertini MR, Flaherty LE, Petrella TM, Streicher H, Sondak VK, Kirkwood JM. Phase III Study of Adjuvant Ipilimumab (3 or 10 mg/kg) Versus High-Dose Interferon Alfa-2b for Resected High-Risk Melanoma: North American Intergroup E1609. J Clin Oncol. 2020 Feb 20;38(6):567–575. PMID: 31880964.

RADT-23. RECURRENT OLIGODENDROGLIOMAS AFTER FIRST CHEMO-RADIATION THERAPY RESPONDED REMARKABLY TO RE-RADIATION

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi46-vi46
Author(s):  
Fumi Higuchi ◽  
Takeo Uzuka ◽  
Keisuke Ueki
Keyword(s):  
Radiation Therapy ◽  
Primary Tumor ◽  
Radiation Treatment ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Lateral Side ◽  
Who Grade ◽  
Recurrent Tumors ◽  
Conventional Radiation ◽  
Before And After

Abstract Oligodendrogliomas with 1p/19q-codeletion are relatively slow progressive tumors that show good response to chemo-radiation therapy after resection. The median survival is about 15 years regardless of WHO grade, although recurrences are mostly inevitable and there is no standard treatment for recurrence. We experienced 5 oligodendroglioma cases who underwent re-radiation for recurrent tumors after chemo-radiation treatment. We retrospectively investigated those for response to re-radiation, the duration from first radiation to second radiation, and Karnofsky Performance Status (KPS) before and after the re-radiation. Patients were all male; the median radiation dose for primary tumor was 60Gy (54-60Gy), the median age at first radiation was 46 years (35-59), the median duration from the first radiation to re-radiation was 65 months (range 18-116 months), and the median follow-up period after re-radiation was 15 months (1-39 months). In all 5 cases, tumors showed good response to re-radiation. In 3 of the 5 cases, tumor recurred in corpus callosum and/or lateral side of cerebral hemisphere or basal ganglia contiguous with primary tumor sites and were radiated by IMRT (50Gy/25fr) . In 2 cases, tumors recurred around the fourth ventricle and posterior fossa and underwent conventional radiation (54Gy/30fr and 30Gy/10fr). In 2 of the 5 cases, the tumors re-recurred 24 months later after re-radiation, but the KPS were maintained until re-recurrence. For oligodendrogliomas, re-radiation therapy appears to be very effective to recurrent tumors after first chemo-radiation. Although evaluation for longer-term side effects is to be examined, re-radiation appears to be a good option for recurrent oligodendrogliomas after first chemo-radiation therapy.

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