Dose intensity of cisplatin and gemcitabine (CG) for muscle invasive urothelial bladder cancer (MIUBC) in the neoadjuvant versus adjuvant settings: The Fox Chase Cancer Center (FCCC) experience

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16012-e16012 ◽  
Author(s):  
J. H. Hoffman-Censits ◽  
Y. Wong ◽  
T. Li ◽  
S. Boorjian ◽  
V. N. Giri ◽  
...  
Keyword(s):  
Performance Status ◽  
Dose Intensity ◽  
Patient Characteristics ◽  
Cancer Center ◽  
Optimal Timing ◽  
Complication Rates ◽  
Ecog Performance Status ◽  
T Stage ◽  
Significant Difference ◽  
Muscle Invasive

e16012 Background: Despite radical cystectomy (RC), subjects with MIUBC remain at risk of recurrence and optimal timing of chemotherapy remains unclear. Historically, we offered adjuvant (ADJ) CG to patients (pts) with T≥3 or node positive tumors. Since Dec 2005, neoadjuvant (NEO) CG treatment has been our preferred approach for pts with ≥T2 tumors. We compare our results with NEO and ADJ CG, including pathologic response after NEO CG. Methods: We reviewed records of patients who underwent RC for MIUBC and received at least 2 cycles of perioperative CG between Jan 2002 and Dec 2008at FCCC. We used Fisher's exact and Wilcoxon tests, as well as Generalized Estimating Equations (GEE), to compare baseline patient characteristics, dose intensity, completion, and complication rates in the ADJ and NEO groups. Results: Results of 22 ADJ and 17 NEO patients are shown below. Characteristics of age, gender, race, preop T stage and ECOG performance status (PS) ≤1 were similar. There was no significant difference in preoperative T stage between groups (p=0.2). The delivery of full doses (C 70mg/m2,G 1000 mg/m2) of GC were similar in the NEO vs the ADJ group. The delay between RC and chemotherapy may be shorter in the patients treated preoperatively, and trended toward significance (p=0.06). Reasons for dose modifications and delays are also shown in the Table . Of pts treated with NEO CG, 10/17 (55.7%) were ≤pT1 with 9 of those 10 pts also pN0 (52.9% of 17 pts) . 5/17 (29.4%) had positive lymph nodes at RC. Conclusions: CG for MIUBC is well tolerated in the NEO setting, with dose intensity comparable to that delivered adjuvantly. NEO pathologic downstaging with CG appears comparable to historical results with MVAC, and should be confirmed in larger, prospective studies. [Table: see text] No significant financial relationships to disclose.

Neoadjuvant cisplatin-based chemotherapy in patients with ureteral obstruction secondary to muscle invasive bladder cancer.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 523-523
Author(s):  
Marshall Strother ◽  
Alexander Kutikov ◽  
Bianca Lewis ◽  
Mengying Deng ◽  
Elizabeth A. Handorf ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Ureteral Obstruction ◽  
Smoking Status ◽  
Performance Status ◽  
Categorical Variables ◽  
Ecog Performance Status ◽  
Significant Difference ◽  
Group A ◽  
Muscle Invasive ◽  
Group B

523 Background: Neoadjuvant cisplatin-based chemotherapy (NAC) followed by cystectomy is the standard of care for muscle-invasive urothelial bladder cancer (MIBC). 15-35% of MIBC patients present with ureteral obstruction. Poor renal function increases cisplatin toxicity. It is unknown whether patients with ureteral obstruction which has been relieved (whether by nephrostomy tube or nephroureteral stent) have the same risk of toxicity as patients without ureteral obstruction. Methods: We retrospectively reviewed an institutional database of all patients undergoing NAC for MIBC with either dose dense MVAC (ddMVAC) or gemcitabine and cisplatin (GC) from January 2004 through May 2017. Patients without ureteral obstruction prior to initiation of NAC (Group A) were compared to those who had ureteral obstruction which was relieved prior to undergoing NAC (Group B). Continuous variables were compared using the Wilcoxon rank-sum test and categorical variables were compared using Fisher’s exact test. The primary outcome was premature discontinuation of NAC, which was defined as failure to complete all planned cycles. Logistic regression was used to test for differences between the groups in this outcome adjusting for age, ECOG performance status, and baseline glomerular filtration rate (GFR). Results: 160 patients in Group A and 59 patients in Group B were identified. Baseline age, Charlson Comorbidity Index, race, smoking status, and ECOG performance status were similar. Patients in Group B had lower GFR (99.2% vs 78.8% p <0.001) and were more likely to be female (21.9% vs 27.3% p <0.025) and to receive ddMVAC (65.0% vs. 83.1% p =0.012). There was no significant difference between groups in rates of premature NAC discontinuation (15.8% vs 22.0% p = 0.284) or grade ≥3 adverse events (23.4% vs 30.5% p = 0.285). Adjusted analysis showed no significant difference between the groups in frequency of premature NAC discontinuation (OR 1.96, 95% CI 0.84-4.57 p=0.12). Conclusions: We detected no difference in frequency of premature discontinuation of NAC in patients with relieved malignant ureteral obstruction relative to patients without obstruction. NAC for MIBC is likely safe in this population.

Phase III study of gemcitabine/oxaliplatin (GEMOX) with or without erlotinib in unresectable, metastatic biliary tract carcinoma.

2011 ◽  
Vol 29 (18_suppl) ◽  
pp. LBA4032-LBA4032 ◽  
Author(s):  
H. Y. Lim ◽  
J. Lee ◽  
H. Chang ◽  
J. S. Kim ◽  
H. J. Choi ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Performance Status ◽  
Progression Free Survival ◽  
Patient Characteristics ◽  
Ampulla Of Vater ◽  
Phase Iii ◽  
Ecog Performance Status ◽  
Standard Regimen ◽  
Tract Cancer ◽  
Significant Difference

LBA4032 Background: Currently, there is no standard regimen for palliative chemotherapy in metastatic, unresectable biliary tract cancer (BTC). A phase II trial of erlotinib monotherapy showed a promising anti-tumor activity in BTC with tolerable toxicity. Additionally, gemcitabine + erlotinib demonstrated superior efficacy when compared to gemcitabine alone in pancreatic cancer. Hence, we conducted a phase III trial to compare between GEMOX vs GEMOX+erlotinib (Tarceva [T]) (GEMOX/T) as first-line chemotherapy in unresectable, metastatic BTC. Methods: Eligible patients were as follows: histologically confirmed adenocarcinoma of biliary tract (CCC), ampulla of vater (AOV) or gall bladder (GB); unresectable or metastatic; ECOG performance status of 0~2; adequate marrow, hepatic, renal and cardiac functions; no prior chemotherapy. The primary endpoint was progression free survival (PFS). The study regimen was gemcitabine 1,000mg/m2, oxaliplatin 100mg/m2, erlotinib 100mg qd daily q 2 weeks. Results: From February 2009 to August 2010, 268 pts were randomized, 133 patients to GEMOX arm and 135 patients to GEMOX/T arm. Patient characteristics: median age 61 yrs (range 30-82); male (63.4%); CCC (n=180, 67.2%), GB (n=82, 30.6%), and AOV (n=6, 2.2%). With a median follow-up of 13.9 months (range, 6.7 – 25.0), median PFS was 5.8 months (95% CI, 4.6 - 7.0) in GEMOX/T arm and 4.2 months (95% CI, 2.7 - 5.7) in GEMOX arm (P=0.080). In subgroup analysis (CCC, n=180), however, median PFS was significantly longer in GEMOX/T arm (5.9 months) when compared with GEMOX arm (3.0 months, P=0.049). The overall response rate was significantly higher in the GEMOX/T arm when compared with GEMOX arm. There was no significant difference in overall survival between the two arms (GEMOX/T: 9.5 months, 95% CI, 7.6 – 11.4; GEMOX: 9.5 months, 95% CI, 7.5 – 11.5; P=0.611). The EGFR mutation testing results in correlation to responsiveness to erlotinib will be presented at the meeting. Conclusions: This phase III represents the first multicenter, randomized trial to compare GEMOX vs GEMOX/T in unresectable, metastatic BTC. Although PFS was not prolonged in GEMOX/T, there was a significant benefit in terms of PFS in GEMOX/T arm for CCC patients.

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.

Abstract WP6: Safety of Acute Carotid Stenting Treatment in Acute Symptomatic Patients

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Darko Quispe-Orozco ◽  
Kaustubh Limaye ◽  
Cynthia Zevallos ◽  
Andrea Holcombe ◽  
Sudeepta Dandapat ◽  
...  
Keyword(s):  
Carotid Stenosis ◽  
Symptom Onset ◽  
Carotid Stenting ◽  
Optimal Timing ◽  
Complication Rates ◽  
Symptomatic Carotid ◽  
Acute Group ◽  
Symptomatic Carotid Stenosis ◽  
Significant Difference ◽  
Delayed Group

Carotid stenting (CAS) has been shown to be equivalent to carotid endarterectomy in symptomatic patients; however its optimal timing remains unclear. In this study, we aim to evaluate the safety of CAS when performed within the first 48 hours of symptom onset. We performed a retrospective analysis of a prospectively collected database of consecutive CAS patients admitted to our comprehensive stroke center with TIA/stroke and ipsilateral symptomatic carotid stenosis >50% from 2014 to 2019. Medical records were retrospectively reviewed for demographic, clinical and procedural data and outcomes. Acute and delayed treatment were defined as ≤48 and >48 hours from last known well (LKW) respectively. The primary endpoint was procedure-related major complications (stroke with NIHSS increase of ≥4, myocardial infarction, parenchymal hemorrhage type 2 or death) ≤30 days after CAS. Secondary endpoints were procedure-related minor neurological (stroke with NIHSS increase of <4 and reperfusion injury) and non-neurological (groin puncture hematoma, acute anemia and arrhythmia) complications. Functional outcome was assessed by discharge and 90 days mRS, dichotomized as good (0-2) and bad (3-6). A total of 72 patients were included in the analysis, 36 in each group. There was no difference in age, NIHSS at presentation, gender, incidence of TIA as presentation or percentage of TPA received. The acute group differed significantly from the delayed group in number of thrombectomies (36.1% vs. 5.6%, p=0.001) and median time from LKW to CAS (15.9 hours vs. 88.0 hours, p<0.001). There were significantly more carotid occlusions in the acute group when compared to the delayed group (37.8% vs. 2.2, p<0.0001). Overall, the acute group did not show significant difference from the delayed group in major (2.8% vs. 5.6%, p=1.0), minor neurological (13.9% vs. 2.8%, p=0.09) and minor non-neurological complication rates (13.9% vs. 8.3%, p=0.7). Rates of good outcomes were not significantly different between the two groups at discharge (52.8% vs. 50%) or 90 days (75% vs. 63%). CAS can be performed safely in acute symptomatic carotid stenosis patients within the first 48 hours from symptom onset.

Development of an aid to decision-making form (ADF) integrated into a major institutional program in oncology: A tool to support care goal identification.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18646-e18646
Author(s):  
Laurence Vigouret-Viant ◽  
Clemence Legoupil ◽  
Aurelie Bardet ◽  
Celine Laurent ◽  
Michel Ducreux ◽  
...  
Keyword(s):  
Decision Making ◽  
Palliative Care ◽  
Intensive Care ◽  
Performance Status ◽  
Medical Decision ◽  
Cancer Center ◽  
P Value ◽  
Ecog Performance Status ◽  
Advance Care ◽  
Aggressive Care

e18646 Background: For cancer patients, life-threatening complications may be difficult to anticipate, leading to complex medical decision-making processes. Since 2015, the Gustave Roussy Cancer Center has implemented a major institutional program including a Decision-Aid Form (ADF), outlining the anticipation of appropriate care for patient in case of worsening evolution. Methods: Between January and May 2017, all patients transferred from Site 1 to Site 2 of the hospital were prospectively included. In this study, we assessed the acceptability of the ADF, its using and its impact on the patient’s becoming. Results: Out of 206 patients included, 89.3% had an ADF. The planned stratification of care was notified in practically all cases. Conversely, the involvement of the palliative care team was notified in only 29% of the ADF. The value of the WHO/ECOG Performance Status was limited, varying between physicians. Finally, the field “information for patients and relatives” was insufficiently completed. Although a possible transfer to Intensive Care Unit was initially proposed in two-thirds of the patients, the majority (76%) of the 35 patients experiencing an acute event received exclusive medical or palliative care. The level of therapeutic commitment suggested by the ADF was never upgraded, and often revised towards less aggressive care, and especially without excess mortality for the patients who were initially designated to be eligible for intensive care. Moreover, the patient's survival at 6 months seems to be correlated with the anticipated level of care recorded on the FAD (Log-rank P value < 0,0001). Conclusions: The results of our study suggest that setting up a care stratification file in advance is possible in a French cultural setting and it could be helpful for clarifying prognosis assessment. To achieve complete acculturation, our extensive institutional program remains a cornerstone for the development of advance care planning. Since 2017, this program has widely spreaded ADF which is now integrated into the electronic medical record. Each physician can complete and modify the patient's ADF at any stage of the patient's disease course.

scholarly journals Urethrovaginal fistula repair with or without concurrent fascial sling placement: A retrospective review

2020 ◽  
Vol 15 (5) ◽  
Author(s):  
Sarah Neu ◽  
Jennifer Locke ◽  
Mitchell Goldenberg ◽  
Sender Herschorn
Keyword(s):  
Patient Characteristics ◽  
Urethral Diverticulum ◽  
Pelvic Surgery ◽  
Study Patient ◽  
Complication Rates ◽  
Urethrovaginal Fistula ◽  
Fascial Sling ◽  
Significant Difference ◽  
Sling Placement

Introduction: We sought to review outcomes of urethrovaginal fistula (UVF) repair, with or without concurrent fascial sling placement. Methods: All patients diagnosed with UVF at our center from 1988–2017 were included in this study. Patient charts were reviewed from a prospectively kept fistula database, and patient characteristics and surgical outcomes were described. Descriptive statistics were applied to compare complication rates between patients with or without fascial sling placement at the time of UVF repair. Results: A total of 41 cases of UVF were identified, all of which underwent surgical repair. Median age at diagnosis was 49 years (interquartile range [IQR] 35–62). All patients had undergone pelvic surgery. UVF etiology was secondary to stress urinary incontinence (SUI) surgery in 17 patients (41%) and urethral diverticulum repair in seven patients (17%). The most common presenting symptom was continuous incontinence in 19 patients (46%). Nineteen patients had a fascial sling placed at the time of surgery (46%), with no significant difference in complication rates (26% vs. 23%, p=0.79). Two patients had Clavien-Dindo grade I complications (5%) and one had a grade III complication (2%). Four patients had long-term complications (10%), including urinary retention, chronic pain, and urethral stricture. Two patients had UVF recurrence (5%). Median followup after surgery was 21 months (IQR 4–72). Conclusions: UVF should be suspected in patients with continuous incontinence following a surgical procedure. Most UVF surgical repairs are successful and can be done with concurrent placement of a fascial sling.

Myeloablative Chemotherapy for T-Cell Lymphoma: a Case for Autologous Stem Cell Transplantatin (Auto) in First Remission.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1141-1141 ◽  
Author(s):  
Issa F Khouri ◽  
Adriana Lopez ◽  
Grace-Julia Okoroji ◽  
Martin Korbling ◽  
Gloria McCormick ◽  
...  
Keyword(s):  
T Cell ◽  
Cell Lymphoma ◽  
Cox Model ◽  
Performance Status ◽  
Autologous Transplantation ◽  
T Cell Lymphoma ◽  
Cancer Center ◽  
P Value ◽  
Significant Difference ◽  
First Remission

Abstract In order to determine the long-term impact of AUTO in patients (pts) with T-cell lymphoma, we examined the outcome of 79 pts transplanted at the MD Anderson Cancer Center, in first partial or complete remission (CR) (AUTO1, n=20) or for relapsed / refractory disease (AUTO2, n=59) between 06/91 and 05/08. &lt;&lt;&lt;PATIENTS&gt;&gt;&gt; Median age (range) at transplantation was 49 (22–65) and 51 (16–77) for the AUTO1 and AUTO2 groups respectively (p=0.35); other baseline characteristics including gender, stage, B-symptoms, LDH, IPI, PET/Gallium status, history of marrow involvement, and performance status at transplantation were similar. There was a statistically significant difference between AUTO1 and AUTO2 with respect to histology {peripheral t-cell, angioimmunoblatic, and anaplastic/large cell were present in 80%, 5%, 15%, respectively in AUTO1, and 42%, 10%, and 45%, respectively in AUTO2 (p=0.02); one pt in AUTO2 had small lymphocytic and one had hepatosplenic T cell lymphoma}. Statistically significant differences were also noted with respect to B2-microglobulin (P=0.02; favoring AUTO1), number of prior chemotherapy regimens received {median 1 vs 3 for AUTO1 and AUTO2, respectively (p &lt;0.001)}, disease status at transplantation {18% of AUTO2 had stable or progressive disease at transplant vs 0% in AUTO1 (P &lt; 0.001)}, and # of CD34+cellsx10 6/Kg infused {median 9 vs 5 for AUTO1 and AUTO2, respectively}. Most pts in both group received BEAM as conditioning. Median follow-up time in months was 64 (95%CI, 31–87), and 47(95%CI29–121) for AUTO1 and AUTO, respectively. Median overall survival (OS) was 43.5 months (95%CI:30–70 for AUTO2 and the median OS was not reached for AUTO1 (P=0.01)(Figure). The median progression-free survival (PFS) was 16 months (95%CI:8–56) and 95 months (95%CI:6.94-NA) for the pts in the AUTO2 and AUTO1 groups, respectively (P=0.06). Univariate Cox models for OS showed that AUTO2 vs AUTO1 (HR 3.4, P=0.02), high LDH level (HR 2.6. P=0.01), PET/Gallium+ (HR 2.8, P=0.01), IPI2–4 (HR 3.4, P=0.002), marrow involvement (HR 6.3, P=0.02), and marrow vs peripheral blood as source of graft (HR 2.1, P=0.048) were important determinants of outcome. The univariate Cox model for PFS showed that only AUTO2 vs AUTO1, hi LDH, IPI and PET/gallium were statistically significant. A multivariate analysis that included the covariates with the lowest P value showed that AUTO2 vs AUTO1 remained the only important factor for OS (HR 4.79, P=0.035) while PET/ Gallium status at transplantation was the most important determinant of PFS (HR 3.13, P=0.006). &lt;&lt;&lt;CONCLUSION&gt;&gt;&gt; Autologous transplantation has the potential to cure a proportion of pts with t-cell lymphoma if performed during the first remission. Alternative strategies are needed for pts transplanted beyond first remission especially if they continue to have avid functional imaging at transplantation. Figure Figure

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.

Pemetrexed and carboplatin plus bevacizumab as first-line therapy for advanced non-squamous non-small cell lung cancer: preliminary safety results of a phase II trial

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17111-17111
Author(s):  
J. D. Patel ◽  
T. A. Hensing ◽  
P. O’Keeffe ◽  
K. Frantonius ◽  
E. Hart ◽  
...  
Keyword(s):  
Treated Patient ◽  
Performance Status ◽  
Single Agent ◽  
Stage Iv ◽  
Patient Characteristics ◽  
Median Number ◽  
Stage Iiib ◽  
Ecog Performance Status ◽  
Minor Response ◽  
First Line Therapy

17111 Background: Bevacizumab is a novel antiangiogenic agent that has been shown to improve response rates and survival of patients with advanced non-squamous NSCLC when added to paclitaxel and carboplatin. Pemetrexed is a multitargeted antimetabolite that has shown activity in NSCLC as a single agent and when combined with carboplatin. Because the combination of pemetrexed and carboplatin has activity comparable to that of other standard platinum doublets and promising toxicity profile (Zinner, 2005), the addition of bevacizumab to this regimen is investigated. Methods: This single cohort, phase 2 study evaluates the safety and efficacy of the combination of pemetrexed and carboplatin plus bevacizumab in patients with untreated non-squamous NSCLC. Eligibility requires ECOG performance status 0–1, Stage IIIB (malignant effusion) or Stage IV non- squamous NSCLC, no evidence of CNS metastases, no anticoagulation. Treatment consists of pemetrexed 500 mg/m2 over 10 minutes, carboplatin AUC 6 over 30 minutes, and bevacizumab 15 mg/kg over 30–90 minutes. Treatment is repeated every 21 days for 6 cycles. For patients who have either stable disease or partial response, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg are continued every 21 days until progression of disease or toxicity. All patients receive folic acid, vitamin B12 and steroid prophylaxis. Tumor response is assessed using RECIST every 2 cycles during treatment with carboplatin and then every 3 cycles during treatment with pemetrexed and bevacizumab alone. Results: From 8/2005 to 12/2005, 10 (of planned 50) patients with Stage IIIB and IV non-squamous NSCLC have been enrolled and treated. Patient characteristics are: median age: 65 (48–71), 20% female, 80% male, 30% stage IIIB, 70% stage IV. Median number of cycles delivered is 5 (range 1–9). No patient has discontinued therapy secondary to progressive disease or toxicity to date. 6 patients are evaluable for response: 1 PR, 1 minor response (24% reduction), 4 SD. No grade 3/4 toxicities have been experienced. Conclusions: This is a highly tolerable and active regimen with little toxicity to date. Updated response and toxicity data will be forthcoming. Supported by Genentech Inc and Lilly Pharmaceuticals. [Table: see text]

Current trend in incidence of severe interstitial lung disease (ILD) due to gefitinib in Japan

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e19075-e19075
Author(s):  
K. Goto ◽  
H. Kenmotsu ◽  
Y. Nishiwaki ◽  
K. Kubota ◽  
H. Ohmatsu ◽  
...  
Keyword(s):  
Incidence Rate ◽  
Performance Status ◽  
Current Trend ◽  
Poor Performance ◽  
Female Gender ◽  
Patient Characteristics ◽  
Japanese Patients ◽  
Cancer Center ◽  
Poor Performance Status ◽  
Almost All

e19075 Background: Although gefitinib is a promising agent for the treatment of advanced non-small cell lung cancer, ILD occurs in Japanese patients and sever ILD sometimes becomes fatal toxicity. ILD has been reported to be associated with preexisting ILD, smoking, and poor performance status. On the other hand, it has been reported that female gender, adenocarcinoma, non-smoker, and EGFR mutation are associated with sensitivity to gefitinib. Methods: To investigate the trend in incidence of severe ILD and patient characteristics receiving gefitinib, a total of 751 patients who were administered gefitinib in National Cancer Center Hospital East between 2002 and 2008 were retrospectively reviewed. To investigate how oncologists avoid administering gefitinib to patients with preexisting ILD, pretreatment chest CT films of all patients were also reviewed by two thoracic radiologists. Results: The patient number who received gefitinib in 2002/2003/2004/2005/2006/2007/2008 were 134/141/88/93/125/98/72, respectively. In these patients, percentages of female were 36/43/42/55/59/52/54%, adenocarcinoma 76/78/93/88/95/93/92%, non-smoker 35/30/40/53/49/48/46%, respectively. Almost all of the patient receiving gefitinib was recently restricted to adenocarcinoma. Grade 3–5 severe ILD was observed in 1.9% of all patients. However, the incidence rate of sever ILD were decreased as 3.0/2.8/2.3/1.1/0.8/1.0/1.4%, respectively. The rates of patients with preexisting ILD were also decreased as 22/14/15/5/2/3/6%, respectively. Conclusions: The correct information about efficacy and severe ILD about gefitinib influenced patient selection by oncologists, and it is reasonable to select more effective and safe patients in Japan. It is estimated that the incidence rate of severe ILD should be consequently controlled by the spread of these information. No significant financial relationships to disclose.

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