Phase II study of chemoradiotherapy with docetaxel for elderly patients with stage II/III esophageal carcinoma: An updated report.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 208-208
Author(s):  
Akihiro Ohba ◽  
Jun Hashimoto ◽  
Ken Kato ◽  
Yoshinori Ito ◽  
Nobukazu Hokamura ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Esophageal Carcinoma ◽  
Clinical Stage ◽  
Performance Status ◽  
Complete Response ◽  
Stage Ii ◽  
Clinical Activity ◽  
Eligibility Criteria ◽  
Resectable Esophageal ◽  
Grade 3

208 Background: Definitive chemoradiotherapy (CRT) is one of the curative options for resectable esophageal carcinoma (EC). However, there are limited data on CRT in elderly patients, and it is difficult for elderly patients to receive chemotherapy containing cisplatin. The aim of this prospective study was to clarify the efficacy and safety of definitive CRT with docetaxel (DTX) in elderly patients. Methods: The eligibility criteria for this study were as follows: clinical stage II-III (UICC 6th, non-T4) EC; performance status (PS) 0-1; age > 70; and no desire for surgical treatment. Chemotherapy consisted of 6 cycles of a 1-h infusion of DTX (10 mg/m2) repeated weekly. Radiation was concurrently applied at a dose of 60 Gy in 30 fractions. We calculated that with a sample size of 37 patients, assuming that the expected and threshold 2-year survival was 50% and 30% with one-sided alpha of 5% with 80% power. Results: Between July 2008 and January 2011, 16 patients were enrolled. The study was closed prematurely due to poor accrual. The median age was 77 years (range, 73-81); male/female: 14/2; PS 0/1: 4/12; clinical Stage IIA/IIB/III: 3/4/9. Of the 16 patients, 14 (88%) completed the CRT, 1 patient (6%) could not complete the treatment because of grade 3 esophagitis, and 1 (6%) refused to continue the treatment. The median follow-up time was 57.9 months. Six patients achieved complete response (CR), resulting in a 37.5% CR rate (95% confidence interval (CI): 15.2-64.6). The 2-year overall survival rate was 62.5% (95% CI: 39.0-86.0). The median survival time was 27.8months (95% CI: 23.7-31.9). Acute toxicities included grade 3/4 esophagitis (31%), anorexia (13%), leukopenia (6%), neutropenia (6%), thrombocytopenia (6%), mucositis (6%), and infection (6%). No treatment-related deaths were observed. Grade 3 or 4 esophagitis, pleural effusion, pericardial effusion, and pneumonitis developed as late adverse events in 13%, 13%, 6%, and 6% of patients, respectively. Conclusions: Although it is difficult to conclude about efficacy of CRT with DTX for elderly stage II-III EC patients, considering that this study was terminated prematurely, CRT with DTX seemed to have substantial clinical activity. Clinical trial information: 000001846.

Preliminary result of a multicenter phase II study of chemoradiotherapy with docetaxel for elderly patients with stage II/III esophageal carcinoma.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 122-122 ◽  
Author(s):  
Jun Hashimoto ◽  
Namiko Kotani ◽  
Nobukazu Hokamura ◽  
Yoshinori Ito ◽  
Chikatoshi Katada ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Esophageal Carcinoma ◽  
Clinical Stage ◽  
Treatment Protocol ◽  
Stage Ii ◽  
Treatment Modalities ◽  
Efficacy And Safety ◽  
Eligibility Criteria ◽  
Grade 3

122 Background: Definitive chemoradiotherapy (CRT) with 5-fluorouracil plus cisplatin (CDDP) is one of the most common treatment modalities for esophageal carcinoma (EC). However, there are limited data on CRT in elderly patients, and it is difficult for elderly patients to receive chemotherapy with CDDP due to poor organ function. The aim of this prospective study was to clarify the efficacy and safety of definitive CRT with docetaxel in elderly patients. Methods: Eligibility criteria included clinical stage II/III (UICC 6th, non-T4) EC, PS 0-1, age over 70 years, and no desire for surgical treatment. A total of 40 patients were planned for enrollment. Chemotherapy consisted of 6 cycles of a 1-h infusion of docetaxel (10 mg/m2) repeated weekly. Radiation was concurrently administered to a dose of 60 Gy in 30 fractions. At this time, we evaluate the preliminary data of efficacy and safety of definitive CRT with docetaxel in elderly patients. Results: A total of 16 patients were enrolled between July 2008 and January 2011, at which point, the trial was closed due to poor accrual. The median age was 77 years (range, 73-81); male/female: 14/2; PS 0/1: 4/12; cStage IIA/IIB/III/IV: 3/4/8/1. Fourteen patients (88%) completed the treatment protocol, 1 patient (6%) could not complete the treatment because of severe toxicities, and 1 (6%) refused to continue the treatment. The complete response (CR) rate was 19% (3/16). In this preliminary analysis, the median follow-up time was 17 months. The 1-year survival rate was 87.5%. The most common grade 3 or 4 toxicities were esophagitis (31%), anorexia (13%), leukopenia (6%), neutropenia (6%), thrombocytopenia (6%), mucositis (6%), and infection (6%). No treatment-related deaths were observed. Grade 3 or 4 esophagitis, pleural effusion, pericardial effusion, and pneumonitis developed as late adverse events in 13%, 13%, 6%, and 6% of patients, respectively. Conclusions: This regimen is considered as feasible on hematological toxicities, however slightly toxic on non-hematological toxicities with modest activity. Lower rate of CR seemed to be due to severe esophagitis. Further follow-up is needed to estimate the efficacy of this treatment.

A Phase II Study of S-1 for Previously Untreated Elderly Patients with Advanced Non-Small Cell Lung Cancer

Chemotherapy ◽  
2015 ◽  
Vol 61 (2) ◽  
pp. 93-98 ◽  
Author(s):  
Takashi Kasai ◽  
Yoichi Nakamura ◽  
Minoru Fukuda ◽  
Takeshi Kitazaki ◽  
Seiji Nagashima ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Elderly Patients ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Response Rate ◽  
Performance Status ◽  
Small Cell ◽  
Small Cell Lung ◽  
Eligibility Criteria ◽  
Grade 3

Background: S-1, a novel oral fluoropyrimidine, is active in the treatment of non-small cell lung cancer (NSCLC). However, data on S-1 for elderly patients with NSCLC are insufficient. Methods: Eligibility criteria were no prior chemotherapy, stage IIIB or IV NSCLC, performance status 0-1, age >70 years, and adequate hematological, hepatic, and renal functions. Patients received S-1 (40 mg/m2 twice a day) for 28 consecutive days. This schedule was repeated every 6 weeks. The primary end point was the tumor response rate. Results: Thirty-two patients were enrolled and 31 patients were evaluable for response. The patients' median age was 80 years (range: 71-88). The response rate was 22.6% (95% CI: 11-38). Neutropenia, anemia, thrombocytopenia, febrile neutropenia, and diarrhea of grade ≥3 occurred in 6, 6, 10, 3, and 3%, respectively. Conclusions: In elderly patients with previously untreated advanced NSCLC, S-1 appears to be well tolerated and demonstrates encouraging activity.

Concomitant radical non-platinum radiochemotherapy for elderly patients with invasive bladder cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16135-e16135
Author(s):  
A. Rodica Maricela ◽  
L. N. Minea ◽  
X. Bacinschi ◽  
I. Isacu ◽  
A. Tarlea
Keyword(s):  
Bladder Cancer ◽  
Elderly Patients ◽  
Performance Status ◽  
Locally Advanced ◽  
Conformal Radiotherapy ◽  
Distant Metastases ◽  
Complete Response ◽  
Bladder Preservation ◽  
Cardiovascular Comorbidities ◽  
Grade 3

e16135 Background: Treatment of bladder cancer in elderly patients is a challenging problem because surgery is often not tolerable and the combination of extensive radiotherapy with chemotherapy is also difficult because of patients’ compliance and associated comorbidities. Our study evaluated concurrent radiochemotherapy in elderly patients with locally advanced bladder cancer (T2-T4) in terms of efficacy and tolerability. Methods: Between January 2005 and December 2007, we treated 34 patients with transitional carcinoma of the bladder, with or without nodal involvement, no distant metastases, and median age 79 years (range 66 - 89 years). Their performance status was 0–1-2 in 10–16–8 patients respectively. Cardiovascular comorbidities were the most common (15 patients). The treatment consisted in conformal radiotherapy (mean irradiation dose = 56.4 Gy) concomitant with biweekly Gemcitabine 200 mg/sqm starting on day 1 of radiotherapy. Results: Response was assessed at 4–6 weeks after the end of treatment by cystoscopy with biopsies and MRI. All the patients could end the intended radiation therapy but four of them could not tolerate all the chemotherapy. 13 patients achieved complete response, 12 patients - partial response and 9 patients stable disease. The most common toxicities were: diarrhea (grade 1–2 in 11 patients, grade 3–6 patients), cystitis (grade 1–2 in 5 patients), leucopenia (grade 1–2 in 12 patients, grade 3–4 in 2 patients), thrombocytopenia (grade 1–2 in 6 patients) and anemia (grade 1–2 in 4 patients). Three patient required hospitalization for dehydration and two for febrile neutropenia. After a median follow-up time of 17.4 months, there were 7 relapses and 5 distant metastases. One-year survival rate was 82.41% (28 patients). 6 patients died, 3 from their cancer and 3 from comorbidities. Conclusions: Chemoradiation is well enough tolerated even in elderly patients and also an efficient and organ sparing therapeutic alternative for patients over 65 years old. The treatment choice was based on patients’ preference considering better quality of life with bladder preservation. The use of age-specific therapy adjustments has shown that aggressive treatment for bladder cancer is associated with improved survival even in elderly patients. No significant financial relationships to disclose.

Comparison of the long-term toxicities conferred by two different doses of definitive chemoradiotherapy for stage II/III esophageal squamous cell carcinoma.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 96-96
Author(s):  
Emi Kubo ◽  
Ken Kato ◽  
Natsuko T. Okita ◽  
Atsuo Takashima ◽  
Yoshitaka Honma ◽  
...  
Keyword(s):  
Cell Carcinoma ◽  
Standard Dose ◽  
Clinical Stage ◽  
Performance Status ◽  
Late Toxicity ◽  
Stage Ii ◽  
Definitive Chemoradiotherapy ◽  
Concurrent Radiotherapy ◽  
Grade 3

96 Background: Definitive chemoradiotherapy is one of the options for stage II/III esophagealsquamous cell carcinoma (ESCC). RTOG9405 recently reported that a higher dose of radiation did not confer any additional survival benefit over the standard dose (50.4 Gy). We comparedthe long-term toxicities conferred by chemoradiation at a dose of 60 Gy and 50.4 Gy for stage II/III ESCC. Methods: Eligibility criteria included clinical stage II/III (non-T4) (UICC-TNM, 6th edition) ESCC, performance status 0-2, and age 20-75 years. The study group comprised 254 patients who received definitive chemoradiotherapy as first-line therapy between January 2000 and August 2010 in our hospital. Group J (n=207) received 2 cycles of cisplatin (40 mg/m2 on days 1 and 8) with fluorouracil infusion (400 mg/m2/day on days 1-5 and 8-12), or 2 cycles of cisplatin(70 mg/m2 on day 1) with fluorouracil infusion (700 mg/m2/day on days 1-4) and concurrent radiotherapy at 60 Gy. Group R (n = 47) received 2 cycles of cisplatin (75 mg/m2 on day 1) with fluorouracil infusion (1000 mg/m2/day on days 1–4) and concurrent radiotherapy at 50.4 Gy. Long-term toxicity was evaluated according to the Common Terminology Criteria for Adverse Event Ver. 3.0. Results: The characteristics of both groups are as follows (J:R group): median age, 64:63; male/female, 178/29:42/5; PS 0/1/2, 90/104/1:33/14/0; stage IIA/IIB/III: 48/58/101:6/20/21. The median follow-up period was more than 60 months for both groups, with 5-year survival rates of 43.6% and 58.6% for the J and R group, respectively. The proportion of patients with grade 3/4 long-term toxicity in each group was as follows (J/R group): pleural effusion, (8.7%/0%; p = 0.036); pericardial effusion, (6.7%/2.1%; p = 0.196); radiation pneumonitis, (2.4%/4.2%); esophagitis, (0.9%/0%); and pericarditis, (2.4%/0%). Grade 3/4 late toxicity was observed more frequently in the J group (15.0%) than in the R group (6.4%) (p = 0.087). Treatment-related death due to pneumonitis was observed in only 1 patient in group J. Conclusions: The RTOG regimen at a dose of 50.4 Gy showed promising results while inducing lower late toxicity rates than when administered at 60 Gy.

Investigation of the tolerability of FOLFIRINOX in patients with unresectable advanced pancreatic cancer: Single-institution experience in Japan.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 487-487 ◽  
Author(s):  
Kouichirou Miyashita ◽  
Takashi Sekikawa ◽  
Ken Shimada ◽  
Taikan Yamamoto ◽  
Yasuhiro Kaga ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Practice ◽  
Clinical Stage ◽  
Performance Status ◽  
Objective Response ◽  
Advanced Pancreatic Cancer ◽  
Dose Intensity ◽  
Eligibility Criteria ◽  
Grade 3 ◽  
Practice Methods

487 Background: FOLFIRINOX therapy has contributed to the overall survival extension of unresectable advanced pancreatic cancer. This regimen is however associated with significant toxicity. And doing the treatment, while careful to toxicity at our institution. We investigated the tolerability of FOLFIRINOX for the treatment of unresectable advanced pancreatic cancer in clinical practice. Methods: We conducted a retrospective analysis of patients with unresectable advanced pancreatic cancer who received FOLFIRINOX between November 2012 and August 2014. FOLFIRINOX is as follows: irinotecan at 150 mg/m2; oxaliplatin at 85 mg/m2; 5-fluorouracil (5FU) at 400mg/m2 bolus, 2,400mg/m2 continuous infusion. Patients' characteristics, objective response, survival and toxicities were collected. Response were evaluated with RECIST version 1.1 and toxicities with NCI-CTCAE version 4.0. Results: 13 patients were includes (8 males and 5 females). Treatment eligibility criteria in our institution were Performance Status 0 or 1, and UGT1A1 polymorphisms were excluded. Median age was 58.6 years (41-74). Clinical stage IVa/IVb was 3/10. The mean number therapy was 7.7 (3-15) cycles. The toxicity of all grade was 100% and grade 3 was 80%. The non-hematological toxicities included nausea in 8 patients (61.5%) and anorexia in 9 (69.2%). The hematological toxicities included neutropenia in 12 patients (92.3%), of which 11 (84.6%) presented a grade 3/4 neutropenia. In patients who developed grade 3 neutropenia, the treatment of FOLFIRINOX could be continued once every three weeks (triweekly) without reducing the dose. Response rate was 38.5% (CR: 0, PR: 5, SD: 6, PD: 2) and disease control rate was 84.6%. Time to treatment failure was 175 days. Relative dose intensity was 95.0% for oxaliplatin, 88.9% for irinotecan, 81.9% for 5FU (bolus), and 95.6% for 5FU (continuous). Conclusions: In clinical practice, it is expected that FOLFIRINOX is an effective, well-tolerated regimen by reducing the dose or determining the appropriate dosing interval.

Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-mutated metastatic non-small cell lung cancer (NSCLC): Interim results of DESTINY-Lung01.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 9504-9504 ◽  
Author(s):  
Egbert F. Smit ◽  
Kazuhiko Nakagawa ◽  
Misako Nagasaka ◽  
Enriqueta Felip ◽  
Yasushi Goto ◽  
...  
Keyword(s):  
Topoisomerase I ◽  
Performance Status ◽  
Objective Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
Clinical Activity ◽  
Antibody Drug Conjugate ◽  
Ecog Performance Status ◽  
Platinum Based Chemotherapy ◽  
Grade 3

9504 Background: T-DXd is an antibody-drug conjugate composed of an anti-HER2 antibody, cleavable tetrapeptide-based linker, and topoisomerase I inhibitor payload. In a phase I trial, patients (pts) with HER2-mutated NSCLC who received T-DXd had a confirmed objective response rate (ORR) of 72.7% (8/11) (Tsurutani et al, WCLC 2018). DESTINY-Lung01 (NCT03505710) is an ongoing, multicenter, phase II study of T-DXd in pts with non-squamous NSCLC overexpressing HER2 or containing a HER2-activating mutation. We report data for the cohort with HER2 mutations after a median follow-up of 8.0 mo (range, 1.4-14.2 mo). Methods: Pts were treated with T-DXd 6.4 mg/kg every 3 weeks. The primary endpoint was confirmed ORR (complete response [CR] + partial response [PR]) by ICR. Additional endpoints were disease control rate (DCR; CR + PR + stable disease), duration of response (DOR), progression-free survival (PFS), and safety. Results: At data cutoff (25 Nov 2019), 42 pts (64.3% female) had received T-DXd. Median age was 63.0 years (range, 34-83 years; < 65 y, 59.5%); 45.2% had central nervous system metastases; ECOG performance status was 0 in 23.8% of pts and 1 in 76.2%. HER2 mutations were predominantly in the kinase domain (90.5%). Most pts (90.5%) had prior platinum-based chemotherapy and 54.8% had anti–PD-1 or –PD-L1 treatment; median number of prior treatment lines was 2 (range, 1-6). Median treatment duration was 7.75 mo (range, 0.7-14.3 mo); 45.2% of pts remained on treatment. Confirmed ORR by ICR among the 42 pts was 61.9% (95% CI, 45.6%-76.4%); median DOR was not reached at data cutoff; 16 of 26 responders remained on treatment at data cutoff; DCR was 90.5% (95% CI, 77.4%-97.3%); estimated median PFS was 14.0 mo (95% CI, 6.4-14.0 mo). All pts (42/42) had treatment-emergent adverse events (TEAEs); 64.3% were grade ≥ 3 (52.4% drug-related), including decreased neutrophil count (26.2%) and anemia (16.7%). There were 5 cases (11.9%) of drug-related interstitial lung disease (ILD) as adjudicated by an independent committee (all grade 2, no grade ≥ 3) and 1 case of grade 1 ILD is pending adjudication. TEAEs led to dose interruption in 25 pts (59.5%), dose reduction in 16 pts (38.1%), and treatment discontinuation in 10 pts (23.8%). Conclusions: T-DXd demonstrated promising clinical activity with high ORR and durable responses in pts with HER2-mutated NSCLC. The safety profile was generally consistent with previously reported studies. Clinical trial information: NCT03505710 .

A multicenter phase II study of cisplatin (C), gemcitabine (G), and bevacizumab (B) as first-line chemotherapy for metastatic urothelial carcinoma (UC): Hoosier Oncology Group GU-0475

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5018-5018
Author(s):  
N. M. Hahn ◽  
W. M. Stadler ◽  
R. T. Zon ◽  
D. M. Waterhouse ◽  
J. Picus ◽  
...  
Keyword(s):  
Performance Status ◽  
Progression Free Survival ◽  
Complete Response ◽  
Phase Iii ◽  
Clinical Activity ◽  
Hematologic Toxicity ◽  
First Line ◽  
Ecog Performance Status ◽  
Angiogenic Therapy ◽  
Grade 3

5018 Background: Despite CG therapy, most metastatic UC patients die from their disease. Novel approaches are needed. Combining anti-angiogenic therapy with chemotherapy has improved outcomes in other malignancies, offering hope for similar improvements in UC patients. Methods: Metastatic or unresectable chemonaive UC patients (pts) with an ECOG performance status of 0–1 received C 70 mg/m2 iv d1, G 1,000–1,250 mg/m2 iv d1, 8, and B 15 mg/kg iv d1 on a q21d cycle for up to 8 cycles. Gemcitabine was reduced to 1,000 mg/m2 iv d1, 8 for all subsequent pts after 7 thromboembolic events were noted in the first 17 pts. The primary endpoint was progression free survival (PFS). The trial was designed to detect a 33% improvement in PFS from 7.5 months with traditional CG therapy to 11.25 months with CGB. Results: By December 2008, 45 pts were enrolled, with 43 evaluable for toxicity, 36 for response. Demographics include: 33 (77%) male, 10 (23%) female; median age 66 (Range: 41 - 78); 26 (60%) and 17 (40%) ECOG 0/1; 19 (44%) and 24 (56%) lymph node only / visceral metastases. PFS will be evaluated in May 2009 when all pts will have more than 6 month follow-up data. 14 (33%) and 6 (14%) pts experienced grade 3 or 4 hematologic toxicity (4 pts - thrombocytopenia, 2 pts - neutropenic fever). Grade 3 or 4 nonhematologic toxicity was observed in 24 (56%) and 9 (21%) pts (DVT/PE - 9 pts, CNS hemorrhage/proteinuria/hypertension - 1 pt each) Best RECIST response was: complete response 6 pts (17%, 95% CI 6–33%), partial response 18 pts (50%, 95% CI 33–67%); with overall response rate of 67% (95% CI 51–82%). Stable disease lasting at least 12 weeks was observed in 10 pts (28%, 95% CI 14–45%) and progressive disease in 2 pts (5%, 95% CI 1–19%). Conclusions: CGB demonstrates significant clinical activity in the first-line treatment of metastatic UC patients at the expense of considerable toxicity. The durability of disease control will be determined by assessment of PFS. A phase III trial to further define the toxicity risk vs. clinical benefit of bevacizumab addition to platinum-based doublets is planned in this population. [Table: see text]

Phase II study of capecitabine in substitution of 5-FU in the chemoradiotherapy regimen for patients with squamous cell carcinoma of the anal canal.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 560-560 ◽  
Author(s):  
Suilane Coelho Ribeiro ◽  
Camila Motta Venchiarutti Moniz ◽  
Rachel Riechelmann ◽  
Giovanni Mendonca Bariani ◽  
Maria Ignez Braghiroli ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Anal Canal ◽  
Cell Carcinoma ◽  
Anal Cancer ◽  
Squamous Cell ◽  
Performance Status ◽  
Complete Response ◽  
Primary Objective ◽  
Stage Ii ◽  
Grade 3

560 Background: Squamous cell carcinoma (SCC) of the anal canal is an uncommon malignancy accounting for 1-5% of intestinal tumors; however, its incidence has been increasing. Treatment for stage II and III anal canal SCC is infusional 5-fluorouracil associated with mitomycin and radiotherapy, since 1974. More convenient treatments for patients are needed. Methods:Patients with SCC of anal cancer T2-4N0M0 or T (any) N1-3M0, with good performance status, normal blood, and renal function were treated with capecitabine 825 mg/m2 12/12hs during radiotherapy associated with a single dose of mitomycin 15 mg/m2 on day 1. Primary objective was local control rate at 6 months determined by clinical examination and radiological assessment. Sample size was calculated using Fleming single stage design. Results: From November/2010 to August/2013 42 patients were initially included, however 36 patients were assessed. Fifteen patients (41.7%) were stage II, 8 patients (22.2%) stage IIIA, and 13 patients (36.1%) stage IIIB. Four patients (11.1%) were HIV-positive, while 32 (88.9%) were HIV-negative. Thirty-two patients finished the treatment, 4 patients are still in treatment. Median follow-up was 18.7 months. Among patients who finished the treatment and were reevaluated at 6 months 4 patients (13.3%) presented partial response, 25 patients (83.3%) had complete response, and 1 patient developed liver metastasis (3.3%). Regarding grade 3-4 toxicities, 7 patients (21.8%) had grade 3 radiodermitis, 1 patient (3.1%) had grade 3 diarrhea, 2 patients (6.2%) had grade 3-4 thrombocytopenia, 3 (9.3%) had lymphopenia and one patient had grade 3 leukopenia. One HIV+ patient had septic shock, pneumonia, herpetic encephalitis and macrophage activation syndrome. Colostomy was required in 2 patients before the beginning of the treatment and 2 patients after the treatment because of local failure, corresponding to a colostomy rate of 12.5%. Conclusions: Capecitabine and mytomicin with radiotherapy seem to be a safe treatment for SCC of the anal cancer.

Combined weekly docetaxel (D) and gemcitabine (G) for relapsed ovarian cancer (OC) and peritoneal cancer (PC): A multi-institutional phase II study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5565-5565
Author(s):  
R. T. Morris ◽  
D. E. Cohn ◽  
J. Fowler ◽  
L. A. Solomon ◽  
A. Vay ◽  
...  
Keyword(s):  
Performance Status ◽  
Single Agent ◽  
Complete Response ◽  
Hepatic Function ◽  
Significant Activity ◽  
Eligibility Criteria ◽  
Peritoneal Cancer ◽  
Platinum Sensitive ◽  
Best Response ◽  
Grade 3

5565 Background: Both D and G have demonstrated single-agent activity in OC and PC. The purpose of this study was to prospectively evaluate the efficacy and toxicity for patients (pts) with relapsed platinum-sensitive (Plat-S) and platinum-resistant (Plat-R) OC or PC treated with combination weekly D and G. Methods: Eligibility criteria included women recurrent or refractory to first line platinum based therapy, a performance status of 2 or better, and adequate renal and hepatic function. Only one prior regimen (including maintenance therapy) was allowed. D (40 mg/m2) and G (800 mg/m2) were administered on days 1 and 8 of a 21 day cycle until progression. Best response was defined by RECIST criteria. Granulocyte stimulating factor prophylaxis was not allowed. There were 2 separate 2-stage designs used, one for each stratum: Plat-R and Plat-S, separately for a total planned sample of 62 pts. The primary endpoint was overall response rate (ORR). This study was approved by each center's institutional review board. Results: Thirty pts were enrolled prior to terminating accrual due to lagging enrollment. The median age was 57.5 years (range 41–80). One pt was diagnosed with PC; the remaining 29 had OC. Twenty-seven (90%) pts were response evaluable. The ORR was 59% (90% confidence interval: 0.44 - 0.73). Six pts (22%) achieved a complete response (CR), 10 pts (37%) achieved a partial response (PR) and one pt (4%) had stable disease. Progressive disease was noted in 10 pts (37%). Plat-S pts (n = 16) had a 69% ORR (CR = 31%, PR = 38%) and Plat-R pts (n = 11) had an ORR of 45% (CR = 9%, PR = 36%). Median overall survival was 12.7 months (Plat-S = 14.2 mos. and Plat-R = 6.7 mos.). Toxicity data were evaluable for 29 (97%) pts. Twelve pts (41%) experienced grade 3 or 4 neutropenia; two of these pts also had documented infections. Three pts had grade 3 anemia and 6 (21%) had grade 3 thrombocytopenia. Dose reductions were uncommon (n = 2, 7%). Twelve pts (41%) were hospitalized at least once during treatment. Conclusions: Weekly D and G combination therapy demonstrates significant activity and moderate toxicity in both Plat-S and Plat-R disease. This non-platinum combination deserves further evaluation and may be considered in pts with Plat-S and Plat-R OC and PC. No significant financial relationships to disclose.

A phase II study evaluating the safety and efficacy of patupilone in patients with platinum refractory/resistant ovarian, primary fallopian, or peritoneal cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5563-5563
Author(s):  
W. M. Smit ◽  
J. Sufliarsky ◽  
T. L. Werner ◽  
D. Dizon ◽  
M. Wagnerova ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Performance Status ◽  
Dose Intensity ◽  
Complete Response ◽  
Clinical Activity ◽  
Average Dose ◽  
Peritoneal Cancer ◽  
Study Results ◽  
Common Grade ◽  
Grade 3

5563 Background: Patients with ovarian cancer that relapse or recur within 6 months after platinum plus taxane therapy have a poor prognosis. Patupilone, a natural epothilone isolated from myxobacterium, is a microtubule targeting agent that was found to be safe and well tolerated, with clinical activity in refractory or resistant ovarian cancer. Methods: Patients were treated with a dose of patupilone 10 mg/m2, given intravenously over 10–20 minutes once every 3 weeks, which was found safe in a previous phase I study. Results: Total 113 women enrolled and 112 were treated. The median age was 56 years (range 18–85 years), and 11 % had WHO Performance Status (PS) of 2. Most patients (104) had ovarian cancer, while 5 were peritoneal and 2 each of fallopian or other origin. All patients had received prior platinum and taxane, and 50% had progressed in less than 3 months after prior platinum therapy. Patients received a median of 4 cycles (range 1–16) of patupilone with median average dose per cycle of 9.97 mg/m2, resulting in a median dose intensity of 100%. The most common grade 3/4 toxicity was diarrhea (21%/3%), fatigue (10%/1%), intestinal obstruction (5%/3%), anorexia (5%/1%), and vomiting (8%/0%). About 38% patients developed neuropathy, which was mostly grade 1 (in 22%), with only 4% patients at grade 3. A total of 6 patients (5.4%) discontinued due to serious adverse event. There were 4 (3.6%) deaths on study, none of which were considered treatment related. The best overall response rate (by RECIST criteria) was 7.1% (95% CI: 3.0%, 14.0%) with no patient having complete response and 8 patients with partial response. Also, 46 patients (41%) had stable disease and 39 (34.8%) progressed, while response was unknown or could not be evaluated in 19 patients. The median PFS is 2.5 months (95% CI: 1.4, 3.5), and median overall survival is 11.2 months (95% CI: 8.3, 14.9), with 33% patients censored. Conclusions: Patupilone 10mg/m2 administered at q3wk was safe and well tolerated. It showed promising activity in patients with refractory/resistant ovarian cancer. [Table: see text]

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