scholarly journals Feasibility and safety of shortened hypofractionated high dose palliative lung radiotherapy – A retrospective planning study

2021 ◽  
Author(s):  
Matthew Jones ◽  
Jane Rogers ◽  
Raj Kumar Shrimali ◽  
Jo Hamilton ◽  
Senthil Athmanathan ◽  
...  
Keyword(s):  
Phase Ii Study ◽  
Palliative Radiotherapy ◽  
Resource Utilisation ◽  
High Dose ◽  
Planning Study ◽  
Potential Safety ◽  
Previously Treated ◽  
Hospital Visits ◽  
Lung Radiotherapy ◽  
Dose Constraints

Objective: Assess the safety and feasibility of shortened hypo-fractionated high dose palliative lung radiotherapy. Methods: Fifteen palliative lung radiotherapy patients previously treated with the standard 36 Gy in 12 fractions (12F) schedule were non-randomly selected to achieve a representative distribution of tumour sizes, volumes, locations and staging. Plans were produced using 30 Gy in 5 fractions (5F) and 30 Gy in 6 fractions (6F) using a 6MV FFF co-planar VMAT technique. These plans were optimised to meet dose constraints for both PTVs and OARs where established OAR constraints were expressed as BED. The potential safety of the delivery of these plans was assessed using these BEDs and also with reductions of 10% and 20% to account for effects of chemotherapy or surgery. Results: For all 5F and 6F plans the mandatory constraints using the full BED were met, as with all 6F plans with 10% BED reductions, but reduced to 6 patients using 5F. Three of 15 5F and 6 of 15 6F plans met the 20% BED reductions. Conclusion: It is potentially safe and feasible to deliver high dose palliative radiotherapy using the 5F or 6F regimes described, when carefully planned to comparable OAR BEDs as for 12F standard. It appears that the toxicity from either of these regimes should be within acceptable limits provided that the dose constraints described can be adhered to. A Phase II study would be required to fully assess the safety and feasibility. The outcomes from such a study could potentially reduce the number of patient hospital visits for radiotherapy, thus benefiting the patient and the clinical service by optimising resource utilisation. Advances in Knowledge: Shortened hypo-fractionated high dose palliative lung radiotherapy is technically feasible provided OAR constraints are respected.

Multicenter sequential phase II study of flavopiridol plus oxaliplatin (Alvocidib) with or without 5-FU and leucovorin (LV) for patients (pts) with refractory germ cell tumors (GCT) including late relapse (LR).

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 364-364 ◽  
Author(s):  
Darren Richard Feldman ◽  
Walter Michael Stadler ◽  
Leonard Joseph Appleman ◽  
David I. Quinn ◽  
Brian Addis Costello ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Germ Cell Tumors ◽  
High Dose Chemotherapy ◽  
Late Relapse ◽  
High Dose ◽  
Stage Design ◽  
Previously Treated ◽  
Tumor Biopsies ◽  
Sequential Phase

364 Background: Flavopiridol + FOLFOX showed activity in refractory GCT pts in a phase I trial (Rathkopf, Clin Cancer Res, 2009). This phase II study assessed the efficacy of this regimen in refractory GCT and the necessity of including 5-FU/LV. Methods: Previously treated pts with progressive GCT were eligible if they had received or were not candidates for high-dose chemotherapy (HDCT). Pts on Arm A received flavopiridol 70mg/m2 plus oxaliplatin 85mg/m2. Arm B (flavopiridol + FOLFOX) tested identical doses of flavopiridol and oxaliplatin plus 5-FU (400mg/m2 bolus, then 1800mg/m2 over 48 hours) and LV 400mg/m2. Treatment was every 2 weeks in 6-week cycles. The primary endpoint was response rate (RR) by RECIST. An identical Simon 2-stage design was used for each arm to differentiate between a RR ≥40% vs. ≤20%, with arm B opening only if arm A was ineffective. With ≥3 responses among the first 12 pts, another 13 pts would be enrolled with responses in ≥8/25 pts needed to show efficacy. Tumor biopsies pre-, during, and post-treatment were assessed by IHC for p53, p21, and cleaved caspase-3. Results: Of 36 pts (7 arm A, 29 arm B), 33 had nonseminoma. Primary site was testis in 27 and mediastinum in 7; 22 pts had received prior HDCT and 13 had LR (>2 years), including 2 on arm A and 11 on arm B. Arm A closed early after 0/7 pts responded (2 SD). Of 25 evaluable pts on arm B, 6 achieved a PR, 9 had SD, and 10 had PD. Notably, 5/10 evaluable LR pts on Arm B had a PR, including 1 pathologic CR, 1 PR-negative markers who received radiation (RT) to a residual bone metastasis, and 1 PR-positive markers who received RT to a residual nodal mass. These 3 pts remain disease-free ≥19 months (m) post-chemotherapy and ≥17m post-RT or surgery. Median PFS and OS were 2.3m and 7.3m for all pts and 3.2m and 11.2m for arm B pts. There was 1 treatment-related death due to sepsis. Conclusions: Although neither arm met the prespecified endpoint, flavopiridol plus FOLFOX (arm B) was particularly active in LR pts, with a 50% overall RR, including several durable responses. Further study of FOLFOX with or without flavopiridol is warranted in LR pts. Correlative data will be presented. Clinical trial information: NCT00957905.

scholarly journals A phase II study of high-dose epirubicin in ovarian cancer patients previously treated with cisplatin

2000 ◽  
Vol 11 (8) ◽  
pp. 1035-1040 ◽  
Author(s):  
J.B. Vermorken ◽  
A. Kobierska ◽  
B. Chevallier ◽  
F. Zanaboni ◽  
A. Pawinski ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Phase Ii Study ◽  
High Dose ◽  
Previously Treated

Carboplatin in the treatment of advanced breast cancer: a phase II study using a pharmacokinetically guided dose schedule.

1993 ◽  
Vol 11 (11) ◽  
pp. 2112-2117 ◽  
Author(s):  
M E O'Brien ◽  
D C Talbot ◽  
I E Smith
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Phase Ii Study ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Dose Schedule ◽  
Advanced Breast ◽  
High Dose ◽  
Previously Treated Patients ◽  
Previously Treated

PURPOSE We performed a phase II study of single-agent carboplatin against metastatic/locally advanced breast cancer using a pharmacokinetically guided dose schedule, to define further the potential role for this agent in combination and high-dose therapy. PATIENTS AND METHODS Forty patients with metastatic/locally advanced breast cancer were treated with carboplatin based on glomerular filtration rate (GFR) to achieve an area under the concentration-versus-time curve (AUC) of 7 mg/mL.min, with each course repeated at 4-week intervals. The median age was 57 years (range, 37 to 71). RESULTS Ten patients achieved a partial response (PR), for an overall response rate of 25% (95% confidence interval, 13% to 41%). One of 13 (8%) previously treated patients responded compared with nine of 27 (33%) patients who had not received previous chemotherapy. Median response duration was 18 weeks (range, 10 to 68). World Health Organization (WHO) grade 2 or greater toxicity was as follows: anemia, 42%; leukopenia, 20%; thrombocytopenia, 35%; nausea/vomiting, 39%; and infection, 9%. CONCLUSION This study confirms other reports indicating that carboplatin has moderate activity in previously untreated patients, but not in previously treated patients. In our view, carboplatin is a more appropriate agent than cisplatin for inclusion in high-dose chemotherapy schedules with autologous bone marrow rescue, and our results support the concept of calculating dose escalation on the basis of the area under the dose-response curve using the Calvert formula, rather than on surface area.

High-dose continuous infusion folinic acid and bolus 5-fluorouracil in patients with advanced colorectal cancer: a phase II study.

1986 ◽  
Vol 4 (7) ◽  
pp. 1058-1061 ◽  
Author(s):  
M Bertrand ◽  
J H Doroshow ◽  
P Multhauf ◽  
D W Blayney ◽  
B I Carr ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Ionizing Radiation ◽  
Continuous Infusion ◽  
Folinic Acid ◽  
Phase Ii ◽  
Initial Dose ◽  
Advanced Colorectal Cancer ◽  
Phase Ii Study ◽  
High Dose ◽  
Previously Treated

Encouraging results have recently been reported for studies using folinic acid in combination with 5-fluorouracil (5-FU) in the treatment of patients with gastrointestinal (GI) malignancies. Thirty-six patients with advanced colorectal cancer with unequivocal evidence of progression while treated with fluoropyrimidines were treated with a six-day continuous infusion of 500 mg/m2/d of folinic acid initiated 24 hours before a five-day course of 5-FU administered as an intravenous (IV) bolus of 370 mg/m2/d. An initial dose of 250 mg/m2/d of 5-FU was used in patients previously treated with ionizing radiation and/or a nitrosourea. Three objective partial responses were observed. The overall median duration of survival was 8.1 months. Toxicity was acceptable and not in excess of that expected for 5-FU alone.

Sign in / Sign up

Export Citation Format

Share Document