Randomized study of docetaxel (D) and dexamethasone (DX) with low or high dose estramustine (E) for patients with advanced hormone-refractory prostate cancer (HRPC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4653-4653
Author(s):  
T. Nelius ◽  
T. Klatte ◽  
F. Reiher ◽  
S. Filleur ◽  
R. Yap ◽  
...  
Keyword(s):  
Overall Survival ◽  
Side Effects ◽  
Bone Pain ◽  
Performance Status ◽  
Univariate Analysis ◽  
Total Daily Dose ◽  
High Dose ◽  
Ecog Performance Status ◽  
Significant Difference ◽  
Psa Response

4653 Background: D-based chemotherapy is a burgeoning option for men with advanced HRPC. Alone or in combination with E, D has been shown to improve median survival. In this study we tested the combination of D with two different doses of E in patients (pts) with HRPC to improve response rates and to lower side effects. Methods: 72 metastatic HRPC pts were randomly assigned to receive D (70 mg/m2 IV, d2, q3w) and E (3 × 280 mg/d PO starting 1 day prior to D, for 5 consecutive days) for arm A or E (3 x 140 mg/d PO starting 1 day prior to D, for 3 consecutive days) for arm B. Premedication with oral DX at a total daily dose of 16 mg, in divided doses two times a day was administered in arm A on day 1 to 5 and in arm B on day 1 to 3. Initially, 6 cycles were administered and repeated after significant PSA rise. Pts were monitored for PSA response, time to progression (TTP), survival and toxicity. Results: PSA declines of ≥75%, ≥50% and ≤50% were 36.8%, 55.3% and 44.7% in arm A and 38.2%, 67.6% and 32.4% in arm B, respectively (P = .442). TTP in Arm A and Arm B were 11 months (95% CI, 7–14) versus 14 months (95% CI, 8–19), P = .6911) and overall survival 21 months (95% CI, 6–35) versus 22 months (95% CI, 18–27), respectively, (P = .4149). The primary treatment-related side effects observed in arm A and arm B were granulocytopenia (34% and 29%, P = .663) and thrombotic complications caused by E (four pts (11%) and one pt (3%), respectively, P = .206). Associated baseline factors with overall survival in univariate analysis were ECOG performance status (P < .001), hemoglobin level (P < .001), bone pain (P < .001), and PSA (P < .097) and in multivariate analysis ECOG performance status (95% CI, 2.9–13.9) and bone pain (95% CI, 3.2–20.1), (P < .001). Conclusions: In this randomized phase II study the combination of D and E had substantial activity in HRPC. We did not find a statistically significant difference of higher dose of E in combination with D compared to a lower dose of E and D regarding PSA response, TTP and survival. However, there was a tendency of higher toxicity in the high dose E group. These treatment-related toxicities were mainly hematologic and manageable. The results of this study support the assertion that estramustine is not necessary in docetaxel-based treatment regimens. No significant financial relationships to disclose.

Phase 3 comparison of high-dose once-daily (QD) thoracic radiotherapy (TRT) with standard twice-daily (BID) TRT in limited stage small cell lung cancer (LSCLC): CALGB 30610 (Alliance)/RTOG 0538.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8505-8505
Author(s):  
Jeffrey A Bogart ◽  
Xiaofei F. Wang ◽  
Gregory A. Masters ◽  
Junheng Gao ◽  
Ritsuko Komaki ◽  
...  
Keyword(s):  
Regional Lymph Node ◽  
Performance Status ◽  
Lymph Node Involvement ◽  
High Dose ◽  
Phase 3 ◽  
Ecog Performance Status ◽  
Once Daily ◽  
Concomitant Boost ◽  
Significant Difference ◽  
Grade 3

8505 Background: Although level 1 evidence is lacking, the majority of patients (pts) with LSCLC are treated with a high dose QD TRT regimen in clinical practice. CALGB 30610/RTOG 0538 was designed to determine if administering high dose TRT would improve overall survival (OS), compared with standard 45 Gy BID TRT, in LSCLC pts treated with chemoradiotherapy. Methods: Eligible pts had LSCLC, ECOG performance status (PS) 0-2 and regional lymph node involvement excluding contralateral hilar or supraclavicular nodes. This phase 3 trial was conducted in 2 stages. In the first stage, pts were randomized 1:1:1 to 45 Gy BID over 3 weeks, 70 Gy QD over 7 weeks, or 61.2 Gy concomitant boost (CB) over 5 weeks. For the second stage, the study planned discontinuation of one high dose arm based on interim toxicity analysis with patients then randomized 1:1 in the two remaining arms. TRT was given starting with either the 1st or 2nd (of 4 total) chemotherapy cycles. The primary endpoint was OS measured from date of randomization. Results: The trial opened 03/15/2008 and closed 12/01/2019 upon completing accrual, with the CB arm discontinued 3/11/2013 after interim analysis. This analysis includes 638 pts randomized to 45 Gy BID TRT (n = 313) or 70 Gy QD TRT (n = 325). Median age was 63 years (range 37-81), the majority of pts were Caucasian (86%), female (52%), and with ECOG PS 0-1 (95%). After median follow-up of 2.84 years (IQR:1.35 -5.61) for surviving pts, QD compared to BID did not result in a significant difference in OS (HR 0.94, 95% CI: 0.76-1.2, p = 0.9). Median, 2- and 4-year OS for QD were 30.5 months (95% CI: 24.4-39.6), 56% (95% CI: 0.51-0.62), and 39% (95% CI: 0.33-0.45), and for BID 28.7 months (95% CI: 26.2-35.5), 59% (95% CI: 0.53-0.65), and 35% (95% CI: 0.29-0.42). QD also did not result in a significant difference in PFS (HR 0.96, 95% CI: 0.78-1.18, p = 0.94). Most grade 3+ hematologic and non-hematologic adverse events (AEs) were similar between cohorts. Rates of grade 3+ febrile neutropenia, dyspnea, esophageal pain and dysphagia for QD were 12.6%,7%, 11.6% and 11.3%, and for BID 13.6%, 4%, 11.2 % and 9.5%. Grade 5 AEs were reported in 3.7% and 1.7% of the QD and BID cohorts, respectively. Results will be updated at presentation. Conclusions: High dose QD TRT to 70 Gy did not significantly improve OS compared with standard 45 Gy BID TRT. Nevertheless, favorable outcomes on the QD arm provide the most robust evidence available supporting high dose once-daily TRT as an acceptable option in LSCLC. Outcomes from this study, the largest conducted in LSCLC to date, will help guide TRT decisions for this patient population. Support: U10CA180821, U10CA180882; Clinical trial information: NCT00632853.

scholarly journals Evaluation of The Effectiveness and Side Effects of Radiotherapy in Patients With Primary Nervous System Lymphoma. A Single Center Experience

2020 ◽  
Vol 7 ◽  
Author(s):  
Timur Koca ◽  
Aylin Fidan Korcum ◽  
Yasemin Şengün ◽  
Melek Gamze Aksu ◽  
Mine Genç
Keyword(s):  
Central Nervous System ◽  
Overall Survival ◽  
Nervous System ◽  
Side Effects ◽  
Disease Free Survival ◽  
Central Nervous System Lymphoma ◽  
Field Size ◽  
High Dose ◽  
Free Survival ◽  
Significant Difference

Aim: In this study, we aimed to evaluate the overall and progression-free survival, the radiotherapy process and the early and late adverse effects in patients who underwent radiotherapy (RT) for primary nervous system lymphoma in our clinic.Method: Between January 2010 and September 2019, 16 patients who received radiotherapy due to primary central nervous system lymphoma in our clinic were examined according to their statistically significant differences in terms of survival and side effects.Results: The median disease-free survival of the patients was 6 months, and the median overall survival was 12.5 months. 18.75% of the patients could not receive chemotherapy but only radiotherapy. Radiotherapy doses were range from 2600 to 5000 cGy. When patients were evaluated in terms of radiotherapy dose, field size and chemotherapy, no statistically significant difference in overall survival was detected. Cognitive disorders were observed as the most common late side effects while the most common acute side effects in patients were headaches.Conclusion: In the treatment of primary central nervous system lymphoma, changes in radiotherapy portals and radiotherapy doses can be predicted in patients who received high-dose methotrexate chemotherapy or not. Furthermore, it has been considered that more comprehensive studies are needed to increase the success of treatment and provide standardization in treatment, especially in patients with elderly and comorbid diseases.

Impact of ECOG performance status on recurrent/metastatic head and neck squamous cell carcinomas treated with anti-PD1 inhibitors.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18004-e18004
Author(s):  
Cameron Chalker ◽  
Vicky Wu ◽  
Jenna M. Voutsinas ◽  
Victoria Hwang ◽  
Christina S Baik ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Outcomes ◽  
Squamous Cell ◽  
Smoking Status ◽  
Demographic Data ◽  
Performance Status ◽  
Univariate Analysis ◽  
Single Agent ◽  
Ecog Performance Status ◽  
Hpv Status

e18004 Background: Anti-PD1 checkpoint inhibitors (ICI) represent an established standard of care for patients with recurrent/metastatic head & neck squamous cell carcinoma (RMHNSCC). Landmark studies excluded patients with ECOG performance status (PS) ≥ 2; the benefit of ICI in this population is therefore unknown. Methods: We retrospectively reviewed RMHNSCC patients who received at least 1 dose of ICI at our institution. Demographic data and clinical outcomes were obtained; the latter included objective response to ICI (ORR), physician-documented CTCAE grade 2+ toxicity (irAE), and any unplanned hospitalization within 100-days of last ICI dose (UH). Associations between demographic data and clinical outcomes were explored using both uni- and multivariate analysis. Overall survival (OS) was estimated using a Cox proportional hazards model; ORR, irAE, and UH were evaluated with logistic regression. This project was approved by our institutional IRB. Results: We identified 152 RMHNSCC patients who were treated with ICI between 1/2013 and 1/2019. ECOG PS was 0 in 42 (27%), 1 in 75 (50%), 2 in 27 (18%), 3 in 2 (1%), and unknown in 6 (4%) patients. The median age was 61 (range: 25 - 90). 124 (82%) were male, 124 (82%) were white, and 69 (45%) were never-smokers. The most common primary sites were the oropharynx (n = 59, 40%), oral cavity (n = 39, 26%), nasopharynx (n = 11, 7%), and larynx (n = 10, 6%). 54 (36%) were p16+ oropharynx cancers. CPS score was available in 10 (6.6%). Single agent ICI was received by 118 (77%) patients. 66 (44%) had a documented irAE and 54 (36%) had an UH. A multivariate model for OS containing PS, smoking status and HPV status showed a strong association between inferior OS and ECOG 2/3 compared to 0/1 (p < 0.001; HR = 3.30, CI = 2.01-5.41), as well as former (vs. never) smoking status (p < 0.001; HR = 2.17, CI = 1.41-3.35). Current smoking (p = 0.25) did not reach statistical significance. On univariate analysis, poor PS was associated with inferior ORR (p = 0.03; OR = 0.25, CI = 0.06-0.77) and increased UH (p = 0.04; OR = 2.43, CI = 1.05—5.71). There was no significant association between irAE and any patient characteristic. Conclusions: We observed inferior overall survival among ICI-treated RMHNSCC patients with ECOG 2/3 in our single-institution, retrospective series. Our findings help frame discussion of therapeutic options in this poor-risk population. Further study must be done to determine which interventions are of greatest benefit for RMHNSCC patients with declining performance status.

Influence of genetic variants of genes potentially associated with colorectal brain metastases on overall survival.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 487-487
Author(s):  
Stefan Stremitzer ◽  
Anna Sophie Berghoff ◽  
Nico Benjamin Volz ◽  
Wu Zhang ◽  
Dongyun Yang ◽  
...  
Keyword(s):  
Overall Survival ◽  
Brain Metastases ◽  
Genetic Variants ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Univariate Analysis ◽  
Nucleotide Polymorphisms ◽  
Primary Tumor Site ◽  
Prognostic Effect ◽  
Significant Difference

487 Background: Brain metastases (BM) in colorectal cancer (CRC) are rare, developing in only 0.3-9% of the patients, and considered a late-stage manifestation of the disease. The aim of this study was to investigate whether genetic variants of genes involved in BM-related pathways, such as integrin, invasion- and adhesion-mediating, angiogenic and tumor suppressing pathways, are associated with outcome. Methods: Genomic DNA was extracted from formalin-fixed paraffin embedded resected BM from 70 patients with histologically proven CRC. Single nucleotide polymorphisms (SNP) in seven genes (CXCR4, MMP9, ST6GALNAC5, ITGAV, ITGB1, ITGB3, KLF4) were analyzed by direct Sanger DNA sequencing and evaluated for association with overall survival (OS) from resection of BM. Only SNPs with an allele frequency of ≥ 10% were analyzed. Results: In univariate analysis, rs17577 (MMP9) and rs4642 (ITGB3) showed a significant difference in OS [(G/G 7.4 months, G/A 5.1 months; HR (95% CI) 1.83 (0.95-3.53), p = 0.0440) and (A/A 9.4 months, A/G 4.8 months, G/G 4.3 months; HR (95% CI) 0.81 (0.44-1.49) and 2.14 (0.98-4.67), p = 0.0354), respectively]. In multivariate analysis adjusted for baseline characteristics [primary tumor site (right colon, left colon, rectal), chemotherapy before BM (yes/no), BM location (supratentorial, infratentorial, both), Karnofsky performance status (<80, 80-100)], rs2236599 (KLF4), and rs10171481 (ITGAV) are significant in OS [(G/G 7.4 months, G/A or A/A 4.8 months; HR (95% CI) 3.19 (1.55-6.53), p = 0.0016) and (A/A 5.7 months, A/G 4.4 months, G/G 15.5 months; HR (95% CI) 0.61 (0.29-1.29) and 0.25 (0.10-0.60), p = 0.0082), respectively]. Conclusions: This study suggests for the first time a prognostic effect of the SNPs involved in the BM pathway. Further analyses are needed to confirm these findings.

Effect of metastasis surgery on overall survival in patients (pts) with advanced soft tissue sarcoma (ASTS): A subanalysis of the PALSAR trials.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 10035-10035
Author(s):  
Nuria Kotecki ◽  
Binh Bui Nguyen ◽  
Jean-Yves Blay ◽  
Simone Mathoulin-Pelissier ◽  
Christine Chevreau ◽  
...  
Keyword(s):  
Overall Survival ◽  
Multivariate Analysis ◽  
Liver Metastasis ◽  
Cox Model ◽  
Performance Status ◽  
Univariate Analysis ◽  
High Dose ◽  
Line Treatment ◽  
Primary Location

10035 Background: The role of surgery in pts with ASTS remains controversial. We have conducted an exploratory retrospective analysis of the role of metastasis surgery in ASTS pts receiving 1st-line chemotherapy (CT). Methods: The database includes all pts enrolled in PALSAR-1 and PALSAR-2 trials [Fayette 2009; Bui-Nguyen 2011], treated with dose-intensified MAID or high-dose CT with peripheral blood stem cells support as 1st-line treatment of ASTS. In our analysis, the primary endpoint is overall survival (OS). Log-ranks are used for univariate analysis and Cox model for multivariate analysis. Impact of treatments had been evaluated after adjustment to confounders (Cox Model). Confounders were defined as parameters with significantly different distribution in pts who underwent metastasis surgery and those who did not (p<0.05) and significantly associated with OS (p<0.05). Results: The database consists of 410 pts (160 in PALSAR-1 and 248 in PALSAR-2) with a median age of 43. Among them, 77 patients (18%) underwent metastasis surgery. At the end of the treatment, 61 pts experienced complete response (CR), 45 with CT alone and 16 with metastasis surgery and CT. The median follow-up was 29 months. The median OS was 35.7 months (29.9-41.5). The following parameters are associated with longer OS in univariate analysis: primary location (p=0.0001), performance status (p=0.010) and absence of liver metastasis (p=0.001). We identified 4 factors associated with metastasis surgery (n=76): limb/trunk primaries, young age, absence of liver metastasis and absence of progression of the target lesions after 4 cycles. The sole identified confounder was primary location. In multivariate analysis the 2 categories of patients experiencing significant longer OS are those with CR without surgery (HR=2.2, [1.7-5.8], p=0.0001) and those with CR following metastasis surgery (HR=3.8, [2.3-6.2], p=0.0001). Conclusions: Among the pts with ASTS receiving poly-CT as 1st-line treatment, the OS of pts experiencing CR with or without metastasis surgery appears similar. Metastatis surgery without CR does not offer significant OS advantage.

P14.76 Bevacizumab (BEV) alone or in combination with chemotherapy in recurrent Glioblastoma Multiforme (GBM): A real world experience

2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii52-ii52
Author(s):  
H I Chalchal ◽  
T Zhu ◽  
C Woitas ◽  
S Ahmed ◽  
O Souied ◽  
...  
Keyword(s):  
Overall Survival ◽  
Glioblastoma Multiforme ◽  
Real World ◽  
Performance Status ◽  
P Value ◽  
Ecog Performance Status ◽  
Number Of Patients ◽  
Significant Difference ◽  
Historic Control ◽  
Recurrent Gbm

Abstract BACKGROUND Patients with glioblastoma multiforme (GBM) have a median survival of about 14 months. In recurrent GBM no active intervention has shown improvement in survival. Clinical trials has shown that bevacizumab (BEV) alone or in combination with chemotherapy is associated with better progression free survival (PFS). The current study aims to assess efficacy of BEV in real-world setting. MATERIAL AND METHODS Population-based retrospective cohort study patients with recurrent GBM diagnosed in the province of Saskatchewan during 2008–2018 and received BEV alone or in combination with chemotherapy were evaluated. Survival was compared with historic control. RESULTS 43 eligible patients with GBM treated with BEV with or without chemotherapy. 25 patients were treated with Bev alone and 18 patients treated with chemotherapy+ BEV. Median age of the patients were noted to be 53 years. 28 male, and 15 female. 80% of patients treated with single agent BEV had a performance status of either 2 or 3 compared to 33% of patient treated with BEV+ chemotherapy. Median PFS was 4.6 months with 95% CI 2.9–6.9. Median Overall survival (OS) from the time of diagnosis was 17.5 month. Median OS from the time of start of BEV was 5.4 months with 95% CI 3.4–6.8. Partial response (PR) was noted in 3 patients (7%) with stable disease (SD) in 6 patients (14%). 33 (77%) had progressive disease (PD). We were unable to confirm response status in one patient (2%). No statistically significant difference in response rate for patients treated with BEV and BEV+ Chemotherapy. From the start of Bev to the best response, 11 patients (30.56%) noted decrease in the dose of steroids, 14 patients (38.89%) dose remained unchanged. 7 patients (19.44%) required increase in the dose of steroids. 4 patients (11.11%) were not on steroids. For 7 patients we did not have the information on use of steroids. PFS was better for patients treated with chemotherapy + BEV with median PFS of 6.9 months, 95% CI 3.2- 22.3 verses BEV alone with median PFS 3.53 months 95% CI 1.4–5.3, P-value 0.0449. The Cox regression model for PFS to test comparing Bev with chemotherapy vs. Bev alone with the co-variables of sex, age, and ECOG performance status (PS). The model showed that patient with higher ECOG PS were noted to have inferior PFS with a Hazard ratio of 1.92 95% CI 1.09–3.37. P value of 0.2. Patient treated with BEV+ chemo had better PFS with a HR of 6.44 95% CI 1.86–22.28. P value of 0.003. CONCLUSION Retrospective real world study confirms that, patients with recurrent GBM, treatment with BEV is associated with similar PFS as reported in literature. Our study showed similar overall survival from the diagnosis compared to historic control. However the Median OS from Start of BEV was noted to be inferior to what is reported in EORTC EH1.3. Better ECOG performance status is associated with better PFS. Higher number of patients with ECOG 2 and 3 received BEV alone.

Improved Survival in Patients with Peripheral T Cell Lymphoma, Unspecified Following High-Dose Therapy and Stem Cell Transplantation: A Retrospective Review of a Single Institution’s Experience.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3062-3062
Author(s):  
Ryan A. Wilcox ◽  
Ahmet Dogan ◽  
Kay Ristow ◽  
Joseph P. Colgan ◽  
Thomas M. Habermann ◽  
...  
Keyword(s):  
Overall Survival ◽  
Stem Cell ◽  
Performance Status ◽  
Complete Response ◽  
High Dose ◽  
High Dose Therapy ◽  
Ecog Performance Status ◽  
First Response ◽  
Hodgkin's Lymphomas ◽  
Disease Free

Abstract Background: Peripheral T-cell non-Hodgkin’s lymphomas (PTCL) account for approximately 10% of all non-Hodgkin’s lymphomas in the U.S. and Europe. PTCL, unspecified (PTCL-U), as classified by the WHO, is the most common subtype. The ability of high-dose therapy (HDT) and stem cell transplantation (SCT) to improve patient outcome was evaluated in the current study. Methods: All patients with PTCL-U evaluated at our institution who had tissue specimens available for review from January, 1994 to December, 2005 were identified and both clinical characteristics and treatment course obtained from the medical record. Results: 89 patients with PTCL-U were identified, with a median follow up of 13 months (range 1 month–12 years). The median age at diagnosis was 56 years (range 24–90). The IPI was low, intermediate or high in 34%, 44% and 22% of patients, respectively. On univariate analysis, age >60 (p<.0001), ECOG performance status >1 (p<.0001), LDH greater than normal (p=.004), Ann Arbor Stage III/IV (p=.01) and the presence of B symptoms (p=.0004) were associated with a poorer overall survival, as was an intermediate or high IPI (p<.0001). In contrast, on multivariate analysis only age >60 (p=.0006) and ECOG performance status >1 (p=.007) were independently associated with poorer overall survival. Fifty-seven percent of patients were treated initially with an anthracycline-based regimen, most commonly CHOP (53%). Patients with a low (0–1), intermediate (2–3) or high (4–5) IPI experienced a 61%, 29% and 18% 5-year overall survival, respectively. Fourteen patients (16%) received HDT and autologous (n=12) or allogeneic (n=2) SCT, either at the time of a first partial or complete response (n=11) or at the time of first relapse (n=3). The median survival in those patients treated initially with an anthracycline-based regimen alone was 11 months (95% CI 0.6–1.6 years). Improvement in both 5-year overall (75% vs 24%, HR=5.6, 95% CI 2.0–23.4, p=.0004) and disease-free (60% vs 26%, HR=3.2, 95% CI 1.3–9.3, p=.008) survival was observed in patients who received HDT/SCT, as compared to patients treated with anthracycline-based therapy alone. Furthermore, improvement in both 5-year overall (80% vs 26%, HR=5.8, 95% CI 1.7–35.7, p=.002) and disease free (72% vs 26%, HR=3.8, 95% CI 1.3–15.8, p=.009) survival was observed in patients who received HDT/SCT at the time of a first partial or complete response when compared to patients who received anthracycline-based therapy. When patients who failed to achieve a first partial or complete response were excluded from the analysis, improved 5-year overall (80% vs 57%, HR=0.5, 95% CI 0.1–2.1, p=.4) and disease-free (72% vs 53%, HR=0.7, 95% CI 0.1–2.3, p=.5) survival were observed in patients who received upfront HDT/SCT, although this failed to reach statistical significance. The improved overall and disease free survival observed in patients receiving HDT/SCT, either at the time of a first response or at the time of relapse, remained significant when accounting for differences in the IPI. In conclusion, selected patients with PTCL-U may benefit from treatment with HDT/SCT following a first response to conventional anthracycline-based chemotherapy.

Clinical variables associated with overall survival in metastatic castration resistant prostate cancer (mCRPC) patients treated with sipuleucel-T immunotherapy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16565-e16565
Author(s):  
Xiao Wei ◽  
Jaselle Perry ◽  
Emily Chang ◽  
Li Zhang ◽  
Robert A. Hiatt ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Performance Status ◽  
Univariate Analysis ◽  
Retrospective Chart Review ◽  
Castration Resistant Prostate Cancer ◽  
Ecog Performance Status ◽  
Prior Chemotherapy ◽  
Ecog Ps ◽  
Baseline Psa

e16565 Background: Sipuleucel-T (Sip-T) is a cellular-based cancer immunotherapy for men with asymptomatic or minimally symptomatic mCRPC. Its approval was based on overall survival (OS) benefit in randomized placebo-controlled phase 3 trials. However, treatment was associated with PSA decline in only a small minority of pts. Understanding clinical factors predictive of OS may help to guide treatment decisions, including pt selection and timing of Sip-T relative to other therapies. Methods: This is a retrospective chart review of mCRPC pts treated with Sip-T at UCSF between April 2010 and April 2016. All pts completed 3 Sip-T infusions. Patients with localized prostate cancer treated with neoadjuvant Sip-T (NCT00715104) and pts with mCRPC treated with an ongoing phase 2 Sip-T/Ipilimumab trial (NCT01804465) were excluded. Kaplan-Meier method was used to estimate OS. The predictive value of candidate variables – including age, ECOG performance status (PS), Gleason score, metastatic volume, baseline PSA, baseline PSADT, prior abiraterone or enzalutamide, and prior chemotherapy – was assessed using univariate and multivariate Cox proportional hazard model. Results: Of 43 patients evaluated to date, 74.4% had ECOG PS 0, 88.4% had bone +/- nodal metastasis, 81.4% had low metastatic volume, 9.3% had prior abiraterone, 2.3% had prior enzalutamide, and 9.3% had prior chemotherapy. The median age was 69 years (range 53-85), median baseline PSA was 8.3 ng/mL (range 0.05-227.9) and median PSA doubling time (PSADT) was 3.9 mo (range 1.4-15.1). At a median follow-up of 21.4 mo, the median OS was 34.1 mo (95% CI 25.7-41.4). Univariate analysis showed that ECOG PS (HR 6.66, p < 0.001) and PSA (log-transformed) (HR 3.36, p = 0.002) were significantly associated with OS. There was a trend towards worse OS with faster baseline PSADT (log-transformed) (HR 0.16, p = 0.11) and prior chemotherapy (HR = 4.13, p = 0.11). By multivariate analysis, ECOG PS, baseline PSA and baseline PSADT were statistically significant (p < 0.05). Conclusions: In this ongoing retrospective cohort, ECOG PS, baseline PSA and baseline PSADT were associated with OS in mCRPC patients treated with Sip-T.

Retrospective analysis of glioblastoma multiforme (GBM) patients treated initially with BCNU compared to temozolomide (TMZ) with concomitant radiation therapy

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2071-2071
Author(s):  
M. Vinjamuri ◽  
R. Adumala ◽  
R. Altaha ◽  
J. Hobbs ◽  
E. Crowell
Keyword(s):  
Overall Survival ◽  
Prognostic Factors ◽  
Retrospective Analysis ◽  
Performance Status ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Survival Curves ◽  
Ecog Performance Status ◽  
Free Survival ◽  
Significant Difference

2071 Background: TMZ and radiation as initial treatment has become the standard of care for GBM. There are no randomized studies comparing TMZ to BCNU in GBM. Methods: We did a retrospective analysis of all 100 GBM patients (pts) diagnosed by our pathology department in the last 10 years. 20 pts were excluded, in 12 pts no chemotherapy was given and there was no data available for 8 pts. BCNU treatment was given in earlier years than TMZ generally. Overall survival (OS), progression free survival (PFS) and four prognostic factors were compared between BCNU and TMZ treated groups. Results: Results show that there is no significant difference in OS and PFS between the two groups. Survival curves were superimposable. This is despite the fact that tumor size and ECOG performance status were worse, though not significantly so in the BCNU group. Age was the only variable that correlated with survival. After correcting for age there was still no difference in PFS and OS between the BCNU and TMZ group. Conclusions: Our study fails to shows superiority of TMZ over BCNU despite the fact that the BCNU group had worse prognostic factors. A randomized comparison of these two agents seems justifiable. [Table: see text] No significant financial relationships to disclose.

scholarly journals [177Lu]Lu-DOTA-ZOL bone pain palliation in patients with skeletal metastases from various cancers: efficacy and safety results

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Madhav Prasad Yadav ◽  
Sanjana Ballal ◽  
Marian Meckel ◽  
Frank Roesch ◽  
Chandrasekhar Bal
Keyword(s):  
Overall Survival ◽  
Pain Assessment ◽  
Bone Pain ◽  
Performance Status ◽  
Response Assessment ◽  
Assessment Criteria ◽  
Skeletal Metastases ◽  
Efficacy And Safety ◽  
Pain Palliation ◽  
Global Pain

Abstract Background [177Lu]Lu-DOTA-ZOL has shown promising results from the dosimetry and preclinical aspects, but data on its role in the clinical efficacy are limited. The objective of this study is to evaluate the efficacy and safety of [177Lu]Lu-DOTA-ZOL as a bone pain palliation agent in patients experiencing pain due to skeletal metastases from various cancers. Methods In total, 40 patients experiencing bone pain due to skeletal metastases were enrolled in this study. The patients were treated with a mean cumulative dose of 2.1 ± 0.6 GBq (1.3–2.7 GBq) [177Lu]Lu-DOTA-ZOL in a median follow-up duration of 10 months (IQR 8–14 months). The primary outcome endpoint was response assessment according to the visual analogue score (VAS). Secondary endpoints included analgesic score (AS), global pain assessment score, Eastern Cooperative Oncology Group Assessment performance status (ECOG), Karnofsky performance status, overall survival, and safety assessment by the National Cancer Institute’s Common Toxicity Criteria V5.0. Results In total, 40 patients (15 males and 25 females) with a mean age of 46.6 ± 15.08 years (range 24–78 years) were treated with either 1 (N = 15) or 2 (N = 25) cycles of [177Lu]Lu-DOTA-ZOL. According to the VAS response assessment criteria, complete, partial, and minimal responses were observed in 11 (27.5%), 20 (50%), and 5 patients (12.5%), respectively with an overall response rate of 90%. Global pain assessment criteria revealed complete, partial, minimal, and no response in 2 (5%), 25 (62.5%), 9 (22.5%), and 4 (10%) patients, respectively. Twenty-eight patients died and the estimated median overall survival was 13 months (95% CI 10–14 months). A significant improvement was observed in the VAS, AS, and ECOG status when compared to baseline. None of the patients experienced grade III/IV haematological, kidney, or hepatotoxicity due to [177Lu]Lu-DOTA-ZOL therapy. Conclusion [177Lu]Lu-DOTA-ZOL shows promising results and is an effective radiopharmaceutical in the treatment of bone pain due to skeletal metastases from various cancers.

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