Detailed Analysis of Neutropenic Risk Factors in Patients with Prostate Cancer Treated with Chemotherapy.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3804-3804
Author(s):  
Elizabeth R. Laber ◽  
Damian A. Laber
Keyword(s):  
Prostate Cancer ◽  
Risk Factors ◽  
Performance Status ◽  
The United States ◽  
Severe Neutropenia ◽  
Ecog Performance Status ◽  
Group 2 ◽  
Grade 3 ◽  
Baseline Psa ◽  
Group 1

Abstract Background: Although thousands of patients (Pts) receive chemotherapy every year in the United States, only few retrospective studies have been done to address the risk factors for chemotherapy (CT) induced neutropenia in patients with cancer. The data in androgen-independent prostate cancer (AIPC) patients is extremely scarce. We decided to perform a retrospective analysis of patients with metastatic AIPC treated with chemotherapy in an open phase II clinical trial looking for predictive factors for neutropenia. Methods: We reviewed the records of all patients with AIPC who completed at least 2 cycles of CT with cyclophosphamide 50 mg/m2, etoposide 50 mg/m2 and estramustine 280 mg orally every night for 14 days out of a 28 day-cycle. We divided the patients into 2 groups according to neutropenia grade 3–4 (Group 1) versus 0–2 (Group 2). Risk factors reviewed included age, number of organs involved with metastases, number of bone metastasis, prior radiotherapy (RT) to the prostate/pelvis, prior number of areas treated with palliative RT, prior CT regimens, baseline PSA, absolute neutrophil count (ANC) and ECOG performance status (PS). Results: See table and figures. Group 1 2 Neutropenia Grade 3–4 0–2 # of Pts 7 11 Age 68 (58–86) 63 (52–74) # organs involved 2.1 1.6 # bone metastases 10.9 9.5 RT prostate/pelvis 0.1 0.4 # palliative RT courses 1 0.6 # prior CT regimens 0.4 0.2 Baseline ANC 3.6 3.8 Baseline PS ECOG 1.3 1.4 Baseline PSA 584 (26–2268) 157 (37–65) Figure Figure Conclusions: Average age and PSA were the only risk factors that were different between the patients who developed severe neutropenia and the ones who did not, albeit not statistically significant. Studies with a larger sample size may detect clinically and statistically significant differences.

E7389, a novel anti-tubulin, in patients with refractory breast cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 653-653 ◽  
Author(s):  
J. BlumL. Forero ◽  
M. K. Heiskala ◽  
N. Meneses ◽  
K. Chandrawansa ◽  
F. Fang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Performance Status ◽  
Safety Data ◽  
Synthetic Analog ◽  
Open Label ◽  
Ecog Performance Status ◽  
Group 2 ◽  
Grade 3 ◽  
Cycle Group ◽  
Group 1

653 Background: E7389 is a synthetic analog of halichondrin B, with a broad anti- proliferative activity against tumor cells. Methods: E7389 was evaluated in an open-label, single-arm Phase II trial as monotherapy for patients with refractory breast cancer (≥2 prior chemotherapy regimens, which must have included an anthracycline and a taxane). E7389 was administered as an IV bolus of 1.4 mg/m2 on Days 1, 8, and 15 of a 28-day cycle (group 1), or on Days 1 and 8 of a 21-day cycle (group 2). The primary efficacy endpoint was ORR. Results: As of 9 December 2005, 88 patients had received treatment, 68 in group 1 and 20 in group 2. Median age was 55 yrs (range 36–84) and ECOG performance status 0–1. Sixty-six percent of the tumors were ductal carcinomas, 6% lobular, and 27% were unclassified. Sixty percent of the tumors were ER+, 47% PR+, and 17% Her2/neu 3+. The patients had received at least two previous regimens, with a median number of 5 (range 2–14). Forty-eight percent of the patients had also used hormonal therapy. Forty-nine patients in group 1 and 12 patients in group 2 had completed their 2nd cycle of treatment, and twenty-one in group1 and 1 in group 2 their 4th cycle. Safety: The major toxicity related to study drug was neutropenia. Among 73 patients with preliminary safety data available, two patients had Grade 3 febrile neutropenia, and 31 had Grade 3 or 4 neutropenia or leukopenia. The other Grade 3 toxicities encountered in more than two patients were dehydration (4 patients) and dyspnea (4 patients). Grade 3 peripheral neuropathy was reported in 2 patients. Efficacy: At the end of cycle four there were 10 (15.2%) confirmed partial responses (PRs) out of 66 evaluable patients in group 1, and 1 confirmed PR (5.6%) out of 18 evaluable patients in group 2. The median duration of confirmed responses was 113 days. Conclusions: Based on the safety and efficacy in this refractory breast cancer population, E7389 appears to be a therapy worthy of continued investigation in patients with heavily pretreated breast cancer. In order to comply with the current demand for individualized cancer care, bio-markers which would predict the sensitivity to E7389 are being searched in the tumor samples of the patients in the current and forthcoming studies. [Table: see text]

Predictors of Early Postoperative Outcomes in 375 Consecutive Hepatectomies: A Single-institution Experience

2013 ◽  
Vol 79 (10) ◽  
pp. 961-966 ◽  
Author(s):  
Mohammad Ali Abbass ◽  
Jeffery M Slezak ◽  
L. Andrew Difronzo
Keyword(s):  
Hepatic Resection ◽  
Performance Status ◽  
Patient Characteristics ◽  
Ecog Performance Status ◽  
Estimated Blood Loss ◽  
Tertiary Center ◽  
Group 2 ◽  
Grade 3 ◽  
Major Hepatectomies ◽  
Group 1

Although the safety of hepatic resection has improved, it is still a highly morbid procedure. A retrospective cohort of 375 patients undergoing hepatectomy (2004 to 2012) was done. All procedures were performed by a single surgeon at a tertiary center. To help identify trends over time, two subgroups were identified: Group 1 (n = 195 from October 2004 to December 2010) and Group 2 (n = 180 from January 2011 to November 2012). The two study groups had similar patient characteristics except there were more patients with cirrhosis in Group 2 (10 vs 17%, P = 0.04). A similar number of major hepatectomies was noted. Median estimated blood loss was 400 mL versus 300 mL ( P = 0.04) in Group 2. Overall complications were more common in Group 1 (54 vs 45%). Fewer Grade 3 or greater Clavien complications (22 vs 13%, P = 0.04) and fewer hospital readmissions were noted in Group 2 (20 vs 8%, P = 0.002). Morbidity was associated with worse Eastern Cooperative Oncology Group (ECOG) performance status, age older than 60 years, and open surgery. Grade 3 or greater Clavien complications were also associated with age older than 60 years, higher American Society of Anesthesiologists class, and worse ECOG status and median estimated blood less greater than 400 mL. Higher Model for End-stage Liver Disease score and advanced ECOG status were correlated with mortality. Outcomes of hepatic resection improved time despite more complex patient characteristics and an equal number of major hepatectomies being performed. However, worse ECOG performance status was a major predictor of postoperative complications and increased mortality.

Combined treatment image guided-intensity modulated radiotherapy (IG-IMRT) plus high-dose rate brachytherapy (HDR) and hormonotherapy (HT) as treatment for high-risk prostate cancer: Five-year result of a phase II study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15571-15571
Author(s):  
B. Guix ◽  
J. Bartrina ◽  
I. Henriquez ◽  
R. Serrate ◽  
P. Palombo ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Dose Rate ◽  
Late Effects ◽  
High Dose Rate ◽  
High Dose ◽  
Group 2 ◽  
Grade 3 ◽  
Group 1

15571 Background: To report early and late toxicity and preliminary biochemical outcome in 345 patients with high-risk (Gleason >=7; PSA>20 or T2c-T3) clinically localized prostate cancer treated with combined high-dose-rate brachytherapy and IMRT (IMRT-HDR) to the prostate and seminal vesicles with 24–36 months of hormononal treatment (goserelin+bicalutamide) (HT). Methods: Between 12/1999 and 10/2003, 345 patients with PSA>20, Gleason score>6 and/or T2c-T3 N0 M0 prostate cancer were treated with IG-IMRT followed by HDR implant to the prostate and HT. Patients were randomly assigned to receive HT for 24 (group 1, 172 patients) or 36 months (group 2, 173 patients). Acute and late toxicities were scored by the EORTC/RTOG morbidity grading scales. Special attention to local, regional or distant recurrence, survival, late effects, PSA and testosterone levels and quality of life was done. PSA failure was defined as nadir +2.0 ng/ml. Results: All patients completed treatment. One patient included in the group 1 and none of the group 2 experienced grade 3 rectal toxicity (rectal ulcer). Seven patients in each group (4.0%) developed acute Grade 2 urinary symptoms, and none experienced urinary retention. No patient (0%) developed Grade 4 rectal complications or grade 3 or 4 urinary complications. With a median follow-up of 44 months, the 5-year actuarial PSA relapse-free survival rates for the whole group of patients was 95.7 %. No statistical differences between group 1 and 2 patients were found. Conclusions: High-dose IG-IMRT+HDR and HT was a safe and effective method of escalating the dose to the prostate without increasing the risk of late effects. Acute and late rectal and urinary complications were significantly low, compared with what has been observed with high-dose conventional, 3D-conformal or IMRT-only. Short-term PSA control rates seem to be at least comparable to those achieved with 3D-EBRT or IMRT. Both treatment regimes were very effective. Longer follow-up is needed to know if better PSA control rate are achieved with longer HT. No significant financial relationships to disclose.

Olaparib (O) in patients (pts) with prostate cancer with BRCA1/2 inactivating mutations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5567-5567
Author(s):  
Evan P. Pisick ◽  
Elizabeth Garrett-Mayer ◽  
Susan Halabi ◽  
Pam K. Mangat ◽  
Eddy Shih-Hsin Yang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Advanced Prostate Cancer ◽  
Performance Status ◽  
Objective Response ◽  
Progression Free Survival ◽  
Ecog Performance Status ◽  
Grade 3 ◽  
Stage 1 ◽  
Anti Tumor Activity ◽  
Inactivating Mutations

5567 Background: TAPUR is a phase II basket study evaluating anti-tumor activity of commercially available targeted agents in pts with advanced cancers with genomic alterations. Advanced prostate cancer (PC) pts with germline or somatic BRCA1/2 inactivating mutations treated with O are reported. Methods: Eligible pts had advanced PC, no remaining standard treatment (tx) options, measurable disease, ECOG Performance Status (PS) 0-2, and adequate organ function. Tumor genomic testing was performed in CLIA-certified, CAP-accredited site selected labs. Pts received O tablets or capsules dosed at 300 mg (n=24) or 400 mg (n=5), respectively, orally twice daily until disease progression. Simon 2-stage design tested the null disease control (DC) (objective response (OR) or stable disease at 16+ weeks (wks) (SD16+) according to RECIST) rate of 15% vs. 35% (power = 0.85; α = 0.10). If ≥2 of 10 pts in stage 1 have DC, 18 more pts are enrolled. If ≥7 of 28 pts have DC, the tx is worthy of further study. Pts had radiographic evaluations at 8 and 16 wks and then every 12 wks. Secondary endpoints are progression-free survival (PFS), overall survival (OS) and safety. Results: 29 pts with BRCA1/2 inactivating mutations were enrolled from Aug 2016 to Jul 2019; 4 were identified as ineligible after enrollment due to bone only disease and removed from analyses. Demographics and investigator-reported outcomes are summarized in the Table. Nine pts with OR and 8 with SD16+ were observed for DC and OR rates of 68% (90% CI: 53% - 77%) and 36% (95% CI: 18% - 57%), respectively. Six pts had at least one grade 3 AE or SAE at least possibly related to O including anemia, aspiration, dehydration, diabetic ketoacidosis, fatigue, and neutropenia. Conclusions: Monotherapy with O showed anti-tumor activity in heavily pre-treated PC pts with germline (1/2 pts with OR or SD16+) or somatic (16/23 pts with OR or SD16+) BRCA1/2 inactivating mutations. These findings extend results from recent trials of O in advanced prostate cancer pts with germline only BRCA1/2 mutations. Clinical trial information: NCT02693535 . [Table: see text]

The fluciclovine (FACBC) PET/CT site-directed therapy of oligometastatic prostate cancer (Flu-BLAST-PC) trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS5099-TPS5099
Author(s):  
Risa Liang Wong ◽  
Sarah K Holt ◽  
Jing Zeng ◽  
Laura Graham ◽  
Rachel Kang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radical Prostatectomy ◽  
The United States ◽  
Abiraterone Acetate ◽  
Ct Imaging ◽  
Definitive Treatment ◽  
Pet Ct ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

TPS5099 Background: Patients with biochemical recurrence (BCR) after local definitive therapy for prostate cancer (PC) represent the largest group of patients alive with PC in the United States. For patients with BCR after both radical prostatectomy and radiation, no further definitive treatment options currently exist as standard of care. FACBC PET/CT is a next-generation imaging modality approved in 2016 for suspected PC recurrence based on elevated PSA levels following prior treatment. FACBC PET/CT allows for earlier detection at lower PSA levels of oligometastatic PC in patients who would otherwise be considered as having micro-metastatic disease. FACBC PET/CT may provide potential targets for site-directed therapy; however, it is unknown whether this approach leads to improvement in clinically relevant outcomes. Methods: Flu-BLAST-PC (ClinicalTrials.gov Identifier: NCT0417543) is a prospective, interventional study enrolling men with PC and BCR who have previously undergone both radical prostatectomy and adjuvant or salvage radiation to the prostatic fossa, with PSA ≥0.5 to < 10 ng/mL, PSA doubling time > 3 to < 18 months, and no radiographically detectable metastases by conventional CT and bone scan imaging. Enrolled patients undergo FACBC PET/CT imaging, and those with no PC metastases detected (Group 1) undergo observation with repeat FACBC PET/CT performed at PSA thresholds of > 2 and > 5 ng/mL, with eligibility for the trial ending at PSA ≥10 ng/mL if FACBC PET/CT remains negative. Those with 1-3 PC regions (defined as radiation fields) detected on FACBC PET/CT (Group 2) undergo site-directed therapy with surgery (e.g. lymphadenectomy) and/or radiation, as well as six months of systemic treatment with androgen deprivation therapy (ADT) and abiraterone acetate with prednisone. Patients with ≥4 PC regions detected on FACBC PET/CT (Group 3) undergo six months of ADT and abiraterone acetate with prednisone without any site-directed therapy. Patients initially in Group 1 who subsequently have PC metastases detected on repeat FACBC PET/CT imaging per protocol join Group 2 or Group 3 based on the number of PC regions involved. Given the long anticipated survival of patients with PC and BCR, the primary endpoint of the study is undetectable PSA ( < 0.2 ng/mL) rate in Group 2 at two years beyond study treatment, with secondary endpoints including the same outcome measure for Group 3, undetectable PSA rate two years after testosterone recovery from ADT in Groups 2 and 3, time to re-initiation of ADT, overall survival, and safety and tolerability. Assuming a null hypothesis of 15% undetectable PSA rate for patients with BCR two years after completing ADT and alternative hypothesis of improvement to 40% in Group 2, planned enrollment is 65 patients in Group 2. This will provide 90% power at the two-sided significance level of 0.05. Five patients have enrolled to date. Clinical trial information: NCT0417543.

High-dose-rate brachytherapy combined with external beam radiotherapy for localized prostate cancer: Correlation between clinical and dosimetric parameters and the incidence of rectal bleeding.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 213-213
Author(s):  
Shinji Kariya ◽  
Ichiro Yamasaki ◽  
Shingo Ashida ◽  
Kenji Tamura ◽  
Taro Shuin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Factors ◽  
Rectal Bleeding ◽  
External Beam Radiotherapy ◽  
Significant Risk ◽  
High Dose Rate ◽  
Localized Prostate Cancer ◽  
High Dose ◽  
Group 2 ◽  
Group 1

213 Background: Several investigators have advocated that the alpha/beta ratio for prostate cancer is atypically low, and that hypofractionated radiotherapy or high-dose-rate brachytherapy (HDR-BT) regimens using appropriate radiation doses are expected to improve the local control rate for localized prostate cancer. However, the increase in the total biological effective dose (BED) may cause increased severity and incidence of normal tissue complications. The purpose of this study was to investigate what clinical and dosimetric factors affected the incidence of rectal bleeding after HDR-BT combined with external beam radiotherapy (EBRT). Methods: A total of 143 patients with localized prostate cancer underwent HDR-BT combined with EBRT. The fractionation schema for HDR-BT and EBRT was prospectively changed: 9 Gy x 2 + 2 Gy x 20 (BED1.5 = 219 Gy, BED3 = 139 Gy) in 57 patients (Group 1); and 9 Gy x 2 + 3 Gy x 13 (BED1.5 = 243 Gy, BED3= 150 Gy) in 86 patients (Group 2). Median follow-up was 59 (range, 36 – 94) months. The toxicities were graded based on the National Cancer Institute-Common Terminology Criteria for Adverse Events v3.0. Results: Sixteen (11.2 %) and one patients developed Grade 2 and 3 rectal bleedings, respectively. There were no significant differences between Group 1 and Group 2 in the incidence of Grade 2 and 3 rectal bleedings (12.3% and 11.6%, respectively). Grade 2 and 3 rectal bleedings occurred much more in the patients receiving the antiplatelet therapy (AT) (19.4%) than those without a history of AT (9.8%) and in the patients with diabetes mellitus (DM) (37.5%) than those without DM (10.4%). However, neither AT nor DM were risk factors in univariate analysis. Regarding dosimetric factors, V75 > 2cc, V90 > 0.2cc, D2 > 7 Gy, and D1 > 7.4 Gy were statistically-significant risk factors. In multivariate analysis, DM was the only statistically-significant risk factor. Conclusions: BED escalation could be performed without severe rectal bleeding in HDR-BT combined with EBRT. V75 > 2cc, V90 > 0.2cc, D2 > 7 Gy, D1 > 7.4 Gy, and DM were risk factors for the incidence of rectal bleeding in HDR-BT combined with EBRT. Clinical trial information: 18-9.

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.

scholarly journals The Effect of Risk Factors on Surgical and Oncological Results in High - Risk Prostate Cancer: A Multicenter Study of the Urooncology Society, Turkey

2021 ◽  
Author(s):  
Volkan Izol ◽  
Nebil Akdogan ◽  
Haluk Ozen ◽  
Bulent Akdogan ◽  
Ali Riza Kural ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Factors ◽  
High Risk ◽  
Progression Rate ◽  
High Risk Prostate Cancer ◽  
Surgical Methods ◽  
Risk Prostate Cancer ◽  
Oncological Results ◽  
Group 2 ◽  
Group 1

Purpose To evaluate the effect of risk factors and selected surgical methods on operative and oncological results of patients undergoing radical prostatectomy (RP) with high-risk prostate cancer (HRPC). Methods Retrospective analysis of patients, who underwent RP for HRPC from 13 urology centers between 1990 to 2019, was performed. Groups were created according to the risk factors of D’Amico classification. Patients with one risk factor were included in group 1 where group 2 consisted of patients with two or three risk factors. Results A total of 1519 patients were included in this study and 1073 (70.6%) patients assigned to group 1 and 446 (29.4%) patients to group 2. Overall (biochemical and/or clinical and/or radiological) progression rate was 12.4% in group 1 and 26.5% in group 2 (p =0.001). Surgical procedure was open RP in 844 (55.6%) patients and minimally invasive RP in 675 (44.4%) patients (laparoscopic and robot-assisted RP in 230 (15.1%) and 445 (29.3%) patients, respectively). Progression rates were similar in different types of operations (p=0.22). Progression rate was not significantly different in patients who either underwent pelvic lymph node dissection (PLND) or not in each respective group. Conclusion RP alone is an effective treatment in the majority of patients with HRPC and PLND did not affect the progression rates after RP. According to the number of preoperative high-risk features, as the number of risk factors increases, there is a need for additional treatment.

Dose escalation by high-dose 3D-conformal radiotherapy (HD-3D-CRT) or low-dose 3D-conformal radiotherapy plus HDR brachytherapy (LD-3D-CRT+HDR-B) for intermediate- or high-risk prostate cancer: Early results of a prospective comparative trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5118-5118
Author(s):  
B. Guix ◽  
J. Bartrina ◽  
J. Tello ◽  
L. Quinzanos ◽  
T. Lacorte
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Conformal Radiotherapy ◽  
High Dose ◽  
Hdr Brachytherapy ◽  
Rectal Toxicity ◽  
Group 2 ◽  
Grade 3 ◽  
Group 1 ◽  
3D Crt

5118 Background: To report early and late toxicity and preliminary biochemical outcome in 445 patients with intermediate- or high-risk clinically localized prostate cancer treated with either HD-3D-CRT or with LD-3D-CRT+HDR-B. Methods: Between December 1999 and October 2005, 445 patients (pts) with PSA'10, Gleason score'6 and/or T2b-T3 N0 M0 prostate cancer entered the study. Pts were assigned to one of the two treatment groups: 76 Gy HD-3D-CRT to the prostate in 38 fractions (group 1; 223 patients) or 46 Gy LD-3D-CRT+ 16 Gy HDR-B given in 2 fractions of 8 Gy (group 2, 222 patients). Both groups were well balanced taking into account patient's as well as tumors’ characteristics. Toxicities were scored by the EORTC /RTOG morbidity grading scales. Special attention to local, regional or distant recurrence, survival, late effects, PSA and testosterone levels and quality of life was done. Results: All pts completed treatment. None pts included in the group 1 or 2 experienced grade 3 rectal toxicity. 28 pts of group 1 (12.5%) and 6 pts of group 2 (2.7%) developed grade 2 rectal toxicity (rectal bleeding or urgency). 15 pts in group 1 (6.7%) and 3 pts in group 2 (1.3%) developed grade 1 rectal bleeding (less than 2 times/week). In group 1 and 2, 81.8%and 95,9% of pts were free from rectal reactions respectively (p < 0.005). 19 pts in each group developed acute Grade 2 urinary symptoms (mainly dysuria), and none experienced urinary retention. No pts (0%) developed Grade 3 or 4 rectal or urinary complications. With a mean follow-up of 55 months, the 5-year actuarial PSA relapse-free survival rates for intermediate- and high-risk group 1 pts were 92 and 91 % respectively and 97 and 96 % for group 2 pts (p < 0.06). Conclusions: High-dose 3D-EBRT +HDR brachytherapy is a safe and effective method of escalating the dose to the prostate without increasing the risk of late effects. Acute and late rectal and urinary complications were significantly reduced with the combined treatment, compared with what was observed with high-dose conventional, 3D-CRT. Short-term PSA control rates tends to be better with in the HDR-boosted patients as spected by higher effective-dose. No significant financial relationships to disclose.

Statins (ASIs) may improve the outcome of erlotinib as second line treatment (tx) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18108-e18108
Author(s):  
Natalie Maimon ◽  
Daniel Keizman ◽  
Maya Gottfried
Keyword(s):  
Cox Model ◽  
Performance Status ◽  
Objective Response ◽  
Progression Free Survival ◽  
Female Gender ◽  
Partial Likelihood ◽  
Second Line ◽  
Ecog Performance Status ◽  
Group 2 ◽  
Group 1

e18108 Background: The EGFR inhibitor erlotinib is a standard second line tx for mNSCLC. Statins are used in the tx of hyperlipidemia. Pre-clinical and clinical studies in several cancer types have shown that they may inhibit tumor growth. Their effect on the outcome of erlotinib as second line tx in mNSCLC is poorly defined. We aimed to study the effect of statins on the outcome of erlotinib as second line tx for mNSCLC. Methods: We performed a retrospective study of an unselected cohort of pts with mNSCLC, who were treated continuously with 150mg of oral erlotinib. Pts were divided into 2 groups: (1) statins users and (2) statins naive. The effect of statins use on objective response, progression free survival (PFS) and overall survival (OS), was tested with adjustment of other known confounding risk factors using a chisquare test and partial likelihood test from cox model. Results: Between 2005-2011, 107 pts with mNSCLC were treated with second line erlotinib. There were 51 statins users (group 1) and 56 nonusers (group 2). All users started statins before erlotinib tx initiation. The groups were balanced regarding the following known clinical prognostic factors: female gender, ECOG performance status, active smoking, anemia, adenocarcinoma histology type, EGFR mutation (positive vs negative + unknown). Objective response in group 1 vs 2 was partial response (PR) 41% vs 29% (p=0.15), stable disease (SD) 41% vs 25% (p=0. 11), and progressive disease (PD) 18% vs 46% (OR=2.5, p=0.07). Median PFS was 12 vs 3 ms (HR 0.44 in statins users, p=0.02). Median OS was 35 vs 19 ms (HR 0.63, p=0.1). Conclusions: Statins may improve the outcome of pts with mNSCLC that are treated with erlotinib as second line tx. This should be investigated prospectively, and if validated, applied in clinical practice and clinical trials.

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