miércoles, 25 de septiembre de 2013

Low-Dose Radiation Therapy (2 Gy × 2) in the Treatment of Orbital Lymphoma

International Journal of Radiation Oncology-Biology-Physics

Volume 86, Issue 5, Pages A1-A30, 805-1014 (1 August 2013)

Low-Dose Radiation Therapy (2 Gy × 2) in the Treatment of Orbital Lymphoma
Carolina E. Fasola, Jennifer C. Jones, Derek D. Huang, Quynh-Thu Le, Richard T. Hoppe, Sarah S. Donaldson

Abstract 
PurposeLow-dose radiation has become increasingly used in the management of indolent non-Hodgkin lymphoma (NHL), but has not been studied specifically for cases of ocular adnexal involvement. The objective of this study is to investigate the effectiveness of low-dose radiation in the treatment of NHL of the ocular adnexa.
Methods and Materials
We reviewed the records of 20 NHL patients with 27 sites of ocular adnexal involvement treated with low-dose radiation consisting of 2 successive fractions of 2 Gy at our institution between 2005 and 2011. The primary endpoint of this study is freedom from local relapse (FFLR).ResultsAt a median follow-up time of 26 months (range 7-92), the overall response rate for the 27 treated sites was 96%, with a complete response (CR) rate of 85% (n=23) and a partial response rate of 11% (n=3). Among all treated sites with CR, the 2-year FFLR was 100%, with no in-treatment field relapses. The 2-year freedom from regional relapse rate was 96% with 1 case of relapse within the ipsilateral orbit (outside of the treatment field). This patient underwent additional treatment with low-dose radiation of 4 Gy to the area of relapse achieving a CR and no evidence of disease at an additional 42 months of follow-up. Orbital radiation was well tolerated with only mild acute side effects (dry eye, conjunctivitis, transient periorbital edema) in 30% of treated sites without any reports of long-term toxicity.
Conclusions
Low-dose radiation with 2 Gy × 2 is effective and well tolerated in the treatment of indolent NHL of the ocular adnexa with high response rates and durable local control with the option of reirradiation in the case of locoregional relapse.

jueves, 12 de septiembre de 2013

BUSCANDO VENTAJAS EN FÁRMACOS CONOCIDOS:

Phase II randomized, double-blind, placebo-controlled study of whole-brain irradiation with concomitant chloroquine for brain metastases

Luis L Rojas-PuentesMarcelino Gonzalez-PinedoAlejando CrismattAlette Ortega-GomezCarlos Gambo-VignolleRodrigo Nuñez-GomezYusmiren Dorantes-Gallareta,Claudia Arce-Salinas and Oscar Arrieta

Radiation Oncology 2013, 8:209 doi:10.1186/1748-717X-8-209
Published: 8 September 2013

Abstract 

Background and purpose Chloroquine (CLQ), an antimalarial drug, has a lysosomotropic effect associated with increased radiationsensibility, which is mediated by the leakage of hydrolytic enzymes, increased apoptosis, autophagy and increased oxidative stress in vitro. In this phase II study, we evaluated the efficacy and safety of radiosensibilization using CLQ concomitant with 30 Gray (Gy) of whole-brain irradiation (WBI) to treat patients with brain metastases (BM) from solid tumors.

Methods

Seventy-three eligible patients were randomized. Thirty-nine patients received WBI (30 Gy in 10 fractions over 2 weeks) concomitant with 150 mg of CLQ for 4 weeks (the CLQ arm). Thirty-four patients received the same schedule of WBI concomitant with a placebo for 4 weeks (the control arm). All the patients were evaluated for quality of life (QoL) using the EORTC Quality of Life (QoL) Questionnaire(EORTC QLQ-C30) questionnaire (Mexican version) before beginning radiotherapy and one month later.

Results

The overall response rate (ORR) was 54% for the CLQ arm and 55% for the control arm (p=0.92). The progression-free survival of brain metastases (BMPFS)rates at one year were 83.9% (95% CI 69.4-98.4) for the CLQ arm and 55.1% (95% CI 33.6-77.6) for the control arm . Treatment with CLQ was independently associated with increased BMPFS (RR 0.31,95% CI [0.1-0.9], p=0.046).The only factor that was independently associated with increased overall survival (OS) was the presence of< 4 brain metastases (RR 1.9, 95% CI [1.12-3.3], p=0.017). WBI was associated with improvements in cognitive and emotional function but also with worsened nausea in both patients groups. No differences in QoL or toxicity were found between the study arms.

Conclusion


Treatment with CLQ plus WBI improved the control of BM (compared with the control arm) with no increase in toxicity; however, CLQ did not improve the RR or OS. A phase III clinical trial is warranted to confirm these findings.

martes, 3 de septiembre de 2013

Insurers Nix Payment for Prostate Cancer Proton Therapy

Roxanne Nelson
Aug 30, 2013
Proton-beam therapy, which is used primarily in the United States, is a controversial alternative to conventional radiotherapy for cancer patients. Proponents argue that it is safer and results in fewer complications and less damage to healthy tissue, but opponents say that, in most cases, the supporting evidence just isn't there, especially considering the exorbitant cost.
The controversy has now reached another level. According toa report in the Wall Street Journal, insurers are now balking at the cost. Two major insurance companies have announced that they no will longer pick up the tab for proton-beam therapy to treat early-stage prostate cancer. A third has joined the fray, saying it will be reviewing its policy later this year.
Blue Shield of California has notified 300 radiation oncology and urology practices in the state that, as of the end of October, it will no longer cover proton-beam therapy for prostate cancer. Ironically, this decision comes just as Scripps Health in San Diego is preparing to open its new proton-beam therapy center, which will be the second in California and the twelfth in the country.
Aetna Inc., the nation's third-largest insurer, stopped covering the procedure for prostate cancer on August 1, and Cigna Corp. says it is planning to review its policy on the therapy later this year.
These are not the first insurers to discontinue coverage. Three years ago, Regence, a BlueCross Blue Shield insurer that operates in 4 states, stopped its coverage for this indication, and Highmark Inc., Pittsburgh, and Blue Cross and Blue Shield of Kansas City do not cover it.
Cost and Lack of Evidence
The major issue with proton therapy is the cost of the treatment and of the treatment facility.
The cost to equip and construct a suitable proton center can range from $25 to $150 million. The acquisition cost for intensity-modulated radiation therapy (IMRT) systems is far less pricey, ranging from $1.8 to $5.4 million, according to a 2009 report by the Institute for Clinical and Economic Review on management options for low-risk prostate cancer.
The treatment also has a much higher price tag. Some data show that for prostate cancer, the median Medicare reimbursement for proton therapy is $32,428 and for IMRT is $18,575.
Although many experts agree that some patients are good candidates for proton therapy — most notably children with central nervous system tumors — its use in prostate cancer is highly controversial.
One expert at the 2013 Annual Meeting of the American Society of Clinical Oncology went so far as to say that "proton radiotherapy sells hope, but there is no clear measurable benefit that we can actually translate and explain to a patient."
"I think you've been spending money on something that, at the moment, doesn't deliver. It may deliver in the future, but that will probably be after my retirement," Frank H. Saran, MD, from the Royal Marsden NHS Foundation Trust in the United Kingdom, told the mainly American audience at the meeting.
Even though proton therapy is supposed to focus the beams more tightly and thereby reduce complication rates, there is no real evidence for this, explained Gerald Chodak, MD, director of the Midwest Prostate and Urology Health Center in Michiana Shores, Indiana, in a Medscape videoblog posted earlier this year.
Proton therapy "is a technology that is at least 30% more costly than IMRT, with no clear evidence that it does reduce long-term side effects and absolutely no data to show that it provides better outcomes," he said.
And, although some centers have been using this technology for a substantial period of time, "we have yet to see a single report talking about long-term mortality," Dr. Chodak added.
Hanging in There
But not all insurers are throwing in the towel. Notably, the federally funded Medicare program is continuing to pay for proton therapy for patients with prostate cancer, and they have not announced any changes in that coverage. However, according to the Hospital Outpatient Prospective Payment System rule for 2013, Medicare did reduce its reimbursementrate for proton therapy.
The mean payment for proton therapy was reduced from $1549 in 2012 to $682 in 2013. This means a 32% drop in revenue, from an average of $35,917 per patient to a projected average of $24,565 per patient, according to the Advisory Board Company, a research and consulting firm.
WellPoint Inc., the second-largest insurance company in the United States, will also continue to cover the procedure, but is negotiating the cost down. Kristin Binns, a spokesperson for WellPoint quoted in the Wall Street Journal report, said that the cost of proton therapy is now comparable to other forms of radiation therapy, at least in some parts of the country. She also said that WellPoint considers proton therapy to be "medically necessary" in certain situations.
Blue Shield is also not throwing in the towel completely. Like WellPoint, it believes that proton therapy has advantages for certain patients, and it will continue to cover the treatment when clinical evidence supports its use, such as in children with certain tumors.


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