Concurrent and adjuvant docetaxel with three dimensional conformal radiation therapy (3-D CRT) for poor-risk localized prostate cancer: A phase II trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5003-5003 ◽  
Author(s):  
J. FERRERO ◽  
M. Bolla ◽  
P. Maingon ◽  
J. Buffet-Miny ◽  
A. Bougnoux ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Acute Toxicity ◽  
Locally Advanced ◽  
Three Dimensional ◽  
Distant Metastases ◽  
Phase Iii ◽  
Respiratory Morbidity ◽  
Conformal Radiation Therapy ◽  
Poor Risk ◽  
Grade 3

5003 Background: Docetaxel increases survival in hormone refractory prostate cancer. The objective of this trial is to evaluate the feasibility of concomitant weekly docetaxel with 3-D CRT and adjuvant docetaxel in unfavorable localized or locally advanced prostate carcinoma. Methods: Sixteen patients with poor risk localized carcinoma (T1c-2b N0M0) and 34 with locally advanced tumors (T3N0- 1M0) according to the 1997 UICC classification, underwent 3-D CRT (72Gy/36 fractions); docetaxel 20mg/m2 iv was delivered concurrently on weeks 1–2-3–5-6–7; adjuvant docetaxel 60mg/m2 q3w started 4 weeks after the completion of radiotherapy for 3 cycles. The patients had to receive LHRH agonist, 6 months to 3 years, according to the number of poor prognostic factors. Acute toxicity was assessed with the NCI CTC v:2.0. Results: From November 2003 to November 2005, 50 patients were included (438 cycles) from six institutions. Median age was 50 years (48–76), median PSA 17.7 ng/ml (3.4–260) and median follow-up 17 months (9–38). Forty six patients completed the chemoradiation regimen (423 cycles), with full dose of docetaxel, 4 patients did not, due to: 1 grade 4 GI toxicity during the cycle 3, 1 grade 3 dysuria after cycle 6, 1 grade 4 myocardial infarction after cycle 6, 1 grade 4 anal fistula between two cycles of adjuvant docetaxel; these patients were excluded. The percentage of grade 3 acute toxicity was 10.8% (5/46): 1 grade 3 neutropenia, 1 grade 3 rectal bleeding, 2 grades 3 diarrhea, 1 grade 3 dysuria. Grade 2 toxicity (nausea, diarrhea and rectitis) were observed, in a percentage of 26%; no grade 2–3 toxicity occurred as regard hypotension, venous thrombosis, peripheral neuropathy, respiratory morbidity, oedemas. Twelve months after the end of the treatment, 44 patients were in complete remission (clinical and biological) and two patients suffer from distant metastases. Conclusion: The feasibility of this combined chemo-radiation regimen deserves to be followed by a phase III trial. No significant financial relationships to disclose.

Survival and toxicity with intensity modulated radiation therapy (IMRT) and chemotherapy for esophageal carcinoma, with or without surgery.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 125-125
Author(s):  
Kristin Kowalchik ◽  
Elizabeth Johnson ◽  
George P. Kim ◽  
C. Daniel Smith ◽  
Siyong Kim ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Acute Toxicity ◽  
Esophageal Carcinoma ◽  
Locally Advanced ◽  
Late Toxicity ◽  
Concurrent Chemotherapy ◽  
Conformal Radiation Therapy ◽  
Trimodality Therapy ◽  
Grade 3 ◽  
3D Crt

125 Background: Treatment for locally advanced esophageal carcinoma is radiation and chemotherapy, with or without surgery. Radiation has traditionally been delivered with 3D conformal radiation therapy (3D CRT). This study evaluates late toxicity in patients treated with IMRT as well as early outcomes and acute toxicity. Methods: This is a retrospective review of 32 patients with esophageal carcinoma treated with IMRT at Mayo Clinic Florida from 2008 -2012. Pathology includes squamous cell and adenocarcinomas. Tumor sites include middle and lower thoracic and GE junction. Clinical stages are TX-T3, N0-3, M0-1. All patients received at least one cycle of concurrent chemotherapy. IMRT dose was 50.4 Gy in 28 fractions prescribed to a target volume including the tumor and regional lymphatics. IMRT plans utilized coplaner beams in a 7-9 beam arrangement or volumetric modulated arc therapy. Results: Median follow-up is 8.9 months (range 2.4-23.0) for all patients and 13.1 months (range 2.8-23.0 months) in surviving patients. Median patient age is 69 (range 46-87). Trimodality treatment was completed in 20 patients (62.5%). Surgery was either an open or minimally invasive esophagogastrectomy. The incidence of grade 3 or greater late toxicity at 1 year was 48% in surgery patients and 26% in non-surgery patients. The most common grade 3 or higher toxicity was esophageal strictures in 25%. The incidence of any grade 3 or greater acute toxicity was 65% in the surgery patients and 75% in the non-surgery patients. Overall survival (OS) for all patients at 18 months is 57% (CI 37-86%) and progression-free survival (PFS) is 60% (36-99%). OS and PFS for trimodality therapy at 12 months is 83% (66-100%) and 81% (63-100%) respectively and for bimodality therapy is 34% (12-93%) and 70% (33-100%) respectively. Conclusions: Increased late toxicity occurs in surgery patients, and increased acute toxicity in non-surgery patients. Lower survival in non-surgery patients may be due to early progression, morbidities which preclude surgery or improved survival with surgery. Overall, IMRT is a feasible treatment modality, which may be equally efficacious to 3D CRT for the treatment of esophageal carcinoma.

Postoperative concurrent radiochemotherapy versus radiotherapy in high-risk SCCA of the head and neck: Results of the German phase III trial ARO 96–3

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5507-5507 ◽  
Author(s):  
R. Fietkau ◽  
C. Lautenschläger ◽  
R. Sauer ◽  
J. Dunst ◽  
A. Becker ◽  
...  
Keyword(s):  
High Risk ◽  
Acute Toxicity ◽  
Head And Neck ◽  
Progression Free Survival ◽  
Distant Metastases ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Free Survival ◽  
Tumor Bed ◽  
Grade 3

5507 Background: Despite resection and postoperative irradiation high-risk (3 or more involved lymph nodes, extra-capsular disease and/or microscopically involved mucosal margins of resection) squamous cell carcinomas (SCCAs) of the head and neck frequently recur in the tumor bed. Postoperatively radiochemotherapy (RCT) with cis-Platin (CDDP)/5-FU versus radiotherapy (RT) alone was compared in a randomized trial. Methods: Between 5/97 and 12/04, 440 patients who had high-risk SCCAs of the head and neck were enrolled in this prospectively randomized phase III trial. Following resection and neck dissection, 214 patients were randomly assigned to RT (66 Gy/33 Fx/6.6 weeks) and 226 patients to identical RT plus CDDP (20 mg/m2 on day 1–5, 29–33) and 5-FU (600 mg/m2 on day 1–5, 29–33). Results: The 5 year local-regional control rate is 72.2 ± 3.7% following RT and 88.6 ± 2.4% for the RCT group (p = 0.00259; 5-year progression free survival 50.1 ± 4.0% and 62.4 ± 4.4% (p = 0.024) and 5-year overall survival 48.6 ± 4.4% vs. 58.1 ± 4.6% (p = 0.11). There was no difference in the 5 year incidence of distant metastases (19.3 ± 3.6% vs 25.5 ± 4.6%; p = 0.45). The incidence of grade 3+ acute toxicity was higher during RCT: mucositis 12.6% vs. 20.8% (p = 0.04), leucopenia 0% vs. 4.4% (p = 0.007). Conclusions: Acute toxicity is increased to an acceptable level by RCT. Postoperative RCT compared to RT improves locoregional control and progression free survival; thus survival as a trend is improved by 10% after 5 years. Supported by Deutsche Krebshilfe 70–2140. No significant financial relationships to disclose.

PANOVA: A phase II study of TTFields (150 kHz) concomitant with standard chemotherapy for front-line therapy of advanced pancreatic adenocarcinoma—Updated efficacy results.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15790-e15790 ◽  
Author(s):  
Manuel Benavides ◽  
Carmen Guillen ◽  
Fernando Rivera ◽  
Javier Gallego ◽  
Jose A. Lopez-Martin ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Cancer Patients ◽  
Metastatic Disease ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Skin Toxicity ◽  
Distant Metastases ◽  
Phase Iii ◽  
Prior Therapy ◽  
Grade 3

e15790 Background: TTFields are a non-invasive, regional antimitotic treatment modality, which has been approved for the treatment of glioblastoma by the FDA. TTFields predominantly act by disrupting the formation of the mitotic spindle during metaphase. TTFields were effective in multiple preclinical models of pancreatic cancer. PANOVA was the first trial testing TTFields in pancreatic cancer patients. Results from the first arm of the study, testing TTFields in combination with gemcitabine, have demonstrated superiority in efficacy compared to historical controls (Rivera F. et al, J Clin Oncol 34, 2016 (suppl 4S; abstr 269). Methods: Twenty advanced pancreatic cancer patients were enrolled in the second arm of PANOVA and treated with TTFields in combination with gemcitabine concomitant to nab-paclitaxel. All patients had unresectable tumors, an ECOG performance score of 0-1 and no prior therapy. The primary endpoint was the incidence and severity of adverse events. Results: The median age was 68.2 (range – 58-81) and most patients (65%) had an ECOG score of 1. Twelve patients (60%) had distant metastases. Ten patients (50%) had serious AEs during the study period. Eleven patients (55%) had treatment-related skin toxicity, of which 5 had grade 3 toxicity. No TTFields-related serious AEs were reported. The median PFS was 12.7 months (95% CI 5.4, NA): 9.3 months in patients with metastatic disease, and not reached in locally-advanced patients. PFS rate at 6 months was 65%: 50% in metastatic disease and 87.5% in locally advanced patients. Of the evaluable tumors, 40% had partial response and another 47% stable disease. The median OS was not reached, and the 1-year survival rate was 72% (62.5% in metastatic disease and 87.5% in locally advanced disease). Conclusions: TTFields concomitant to gemcitabine and nab-paclitaxel are safe for advanced pancreatic cancer patients, with promising clinical outcome which doubled historical data. A phase III trial is planned, testing the efficacy of TTFields combined with gemcitabine and nab-paclitaxel in locally-advanced pancreatic cancer patients. Clinical trial information: NCT01971281.

Phase I/II Study of Biweekly Paclitaxel and Radiation in Androgen-Ablated Locally Advanced Prostate Cancer

2008 ◽  
Vol 26 (18) ◽  
pp. 2973-2978 ◽  
Author(s):  
Nicholas J. Sanfilippo ◽  
Samir S. Taneja ◽  
Abraham Chachoua ◽  
Herbert Lepor ◽  
Silvia C. Formenti
Keyword(s):  
Prostate Cancer ◽  
Advanced Prostate Cancer ◽  
Locally Advanced ◽  
Maximum Tolerated Dose ◽  
Phase Iii ◽  
Locally Advanced Prostate Cancer ◽  
Number Of Patients ◽  
Grade 3 ◽  
Experienced Grade

Purpose To determine the maximum-tolerated dose (MTD) of concurrent paclitaxel and radiation therapy (RT) in patients with locally advanced prostate cancer. Materials and Methods Eligible patients had T2-4 tumors with Gleason scores greater than 7 and/or PSA levels greater than 10 ng/mL and/or had tumors with pathologic stage TxN1. Hormonal ablation was initiated 3 months before RT and was given for 9 months. RT was delivered daily (1.8 Gy) with concurrent twice-weekly paclitaxel (30 mg/m2). The whole pelvis was irradiated to 39.6 Gy. The radiation dose was escalated as follows: 63 Gy, 66.6 Gy, 70.2 Gy, and 73.8 Gy. The last RT dose level was fixed at 73.8 Gy. Results Between January 2000 and October 2006, 22 patients were enrolled. The median age was 59 years (range, 48 to 72 years); the median PSA level was 22.4 ng/mL (range, 2.8 to 113 ng/mL). The number of patients per stage was as follows: three with T1, eight with T2, 11 with T3, and five with pN1 = 5. No grade 3 toxicities occurred at 63 Gy. Grade 3 diarrhea occurred in three patients at 66.6 Gy. The protocol then was amended to treat the prostate volume first followed by the whole pelvis. No grade 3 toxicities were observed at 70.2 Gy. One patient experienced grade 3 diarrhea at 73.8 Gy. Five additional patients were treated to 73.8 Gy without grade 3 toxicity, which established the MTD for combined paclitaxel and RT at 73.8 Gy. At 38 months median follow-up (range, 9 to 87 months), 21 (95%) of 22 patients are alive. Six (27%) of 22 experienced recurrence. Conclusion Concurrent biweekly paclitaxel with RT is feasible, with an MTD of 73.8 Gy. Recovery of gonadal function occurs in the majority of patients. These results encourage testing in a phase III setting.

scholarly journals Carbon ion radiotherapy for prostate cancer with bladder invasion

BMC Urology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yuhei Miyasaka ◽  
Hidemasa Kawamura ◽  
Hiro Sato ◽  
Nobuteru Kubo ◽  
Tatsuji Mizukami ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Locally Advanced ◽  
Therapeutic Benefit ◽  
Carbon Ion Radiotherapy ◽  
Safety And Efficacy ◽  
Carbon Ion ◽  
Grade 3 ◽  
Bladder Invasion

Abstract Background The optimal management of clinical T4 (cT4) prostate cancer (PC) is still uncertain. At our institution, carbon ion radiotherapy (CIRT) for nonmetastatic PC, including tumors invading the bladder, has been performed since 2010. Since carbon ion beams provide a sharp dose distribution with minimal penumbra and have biological advantages over photon radiotherapy, CIRT may provide a therapeutic benefit for PC with bladder invasion. Hence, we evaluated CIRT for PC with bladder invasion in terms of the safety and efficacy. Methods Between March 2010 and December 2016, a total of 1337 patients with nonmetastatic PC received CIRT at a total dose of 57.6 Gy (RBE) in 16 fractions over 4 weeks. Among them, seven patients who had locally advanced PC with bladder invasion were identified. Long-term androgen-deprivation therapy (ADT) was also administered to these patients. Adverse events were graded according to the Common Terminology Criteria for Adverse Event version 5.0. Results At the completion of our study, all the patients with cT4 PC were alive with a median follow-up period of 78 months. Grade 2 acute urinary disorders were observed in only one patient. Regarding late toxicities, only one patient developed grade 2 hematuria and urinary urgency. There was no grade 3 or worse toxicity, and gastrointestinal toxicity was not observed. Six (85.7%) patients had no recurrence or metastasis. One patient had biochemical and local failures 42 and 45 months after CIRT, respectively. However, the recurrent disease has been well controlled by salvage ADT. Conclusions Seven patients with locally advanced PC invading the bladder treated with CIRT were evaluated. Our findings seem to suggest positive safety and efficacy profiles for CIRT.

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