Precision Hypofractionated Radiation Therapy in Poor Performing Patients With Non-Small Cell Lung Cancer: Phase 1 Dose Escalation Trial
Kenneth D. Westover, MD, PhD, Billy W. Loo Jr., MD, PhD, David E. Gerber, MD, Puneeth Iyengar, MD, PhD, Hak Choy, MD, Maximilian Diehn, MD, PhD, Randy Hughes, MD, Joan Schiller, MD, Jonathan Dowell, MD, Zabi Wardak, MD, David Sher, MD, MPH, Alana Christie, MS, Xian-Jin Xie, PhD, Irma Corona, Akanksha Sharma, Margaret E. Wadsworth, MD, Robert Timmerman, MDcorrespondenceemail
Received: January 20, 2015; Received in revised form: April 29, 2015; Accepted: May 4, 2015; Published Online: May 08, 2015
Purpose
Treatment regimens for locally advanced non-small cell lung cancer (NSCLC) give suboptimal clinical outcomes. Technological advancements such as radiation therapy, the backbone of most treatment regimens, may enable more potent and effective therapies. The objective of this study was to escalate radiation therapy to a tumoricidal hypofractionated dose without exceeding the maximally tolerated dose (MTD) in patients with locally advanced NSCLC.
Methods and Materials
Patients with stage II to IV or recurrent NSCLC and Eastern Cooperative Oncology Group performance status of 2 or greater and not candidates for surgical resection, stereotactic radiation, or concurrent chemoradiation were eligible. Highly conformal radiation therapy was given to treat intrathoracic disease in 15 fractions to a total of 50, 55, or 60 Gy.
Results
Fifty-five patients were enrolled: 15 at the 50-Gy, 21 at the 55-Gy, and 19 at the 60-Gy dose levels. A 90-day follow-up was completed in each group without exceeding the MTD. With a median follow-up of 12.5 months, there were 93 grade ≥3 adverse events (AEs), including 39 deaths, although most AEs were considered related to factors other than radiation therapy. One patient from the 55- and 60-Gy dose groups developed grade ≥3 esophagitis, and 5, 4, and 4 patients in the respective dose groups experienced grade ≥3 dyspnea, but only 2 of these AEs were considered likely related to therapy. There was no association between fraction size and toxicity (P=.24). The median overall survival was 6 months with no significant differences between dose levels (P=.59).
Conclusions
Precision hypofractionated radiation therapy consisting of 60 Gy in 15 fractions for locally advanced NSCLC is generally well tolerated. This treatment regimen could provide patients with poor performance status a potent alternative to chemoradiation. This study has implications for the cost effectiveness of lung cancer therapy. Additional studies of long-term safety and efficacy of this therapy are warranted.
viernes, 16 de octubre de 2015
SBRT and Quality of life
Prospective Longitudinal Assessment of Quality of Life for Liver Cancer Patients Treated With Stereotactic Body Radiation Therapy
Jonathan Klein, MDcorrespondenceemail
, Laura A. Dawson, MD , Haiyan Jiang, PhD , John Kim, MD , Rob Dinniwell, MD , James Brierley, MBBS, Rebecca Wong, MBChB, MSc, Gina Lockwood, MMath, Jolie Ringash, MD, MSc
Purpose
To evaluate quality of life (QoL), an important outcome owing to poor long-term survival, after stereotactic body radiation therapy (SBRT) to the liver.
Methods and Materials
Patients (n=222) with hepatocellular carcinoma (HCC), liver metastases, or intrahepatic cholangiocarcinoma and Child-Pugh A liver function received 24-60 Gy of 6-fraction image-guided SBRT. Prospective QoL assessment was completed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and/or Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep, version 4) questionnaires at baseline and 1, 3, 6, and 12 months after treatment. Ten HCC patients with Child-Pugh B liver function were also treated.
Results
The QLQ-C30 was available for 205 patients, and 196 completed the FACT-Hep. No difference in baseline QoL (P=.17) or overall survival (P=.088) was seen between the HCC, liver metastases, and intrahepatic cholangiocarcinoma patients.
Appetite loss and fatigue measured by the QLQ-C30 clinically and statistically worsened by 1 month after treatment but recovered by 3 months. At 3 and 12 months after treatment, respectively, the FACT-Hep score had improved relative to baseline in 13%/19%, worsened in 36%/27%, and remained stable in 51%/54%. Using the QLQ-C30 Global Health score, QoL improved in 16%/23%, worsened in 34%/39%, and remained stable in 50%/38% at 3 and 12 months, respectively.
Median survival was 17.0 months (95% confidence interval [CI] 12.3-19.8 months). Higher baseline scores on both FACT-Hep and QLQ-C30 Global Health were associated with improved survival. Hazard ratios for death, per 10-unit decrease in QoL, were 0.90 (95% CI 0.83-0.98; P=.001) and 0.88 (95% CI 0.82-0.95; P=.001), respectively. Tumor size was inversely correlated with survival.
Conclusions
Liver SBRT temporarily worsens appetite and fatigue, but not overall QoL. Stereotactic body radiation therapy is well tolerated and warrants comparison against other liver-directed therapies.
Jonathan Klein, MDcorrespondenceemail
, Laura A. Dawson, MD , Haiyan Jiang, PhD , John Kim, MD , Rob Dinniwell, MD , James Brierley, MBBS, Rebecca Wong, MBChB, MSc, Gina Lockwood, MMath, Jolie Ringash, MD, MSc
Purpose
To evaluate quality of life (QoL), an important outcome owing to poor long-term survival, after stereotactic body radiation therapy (SBRT) to the liver.
Methods and Materials
Patients (n=222) with hepatocellular carcinoma (HCC), liver metastases, or intrahepatic cholangiocarcinoma and Child-Pugh A liver function received 24-60 Gy of 6-fraction image-guided SBRT. Prospective QoL assessment was completed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and/or Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep, version 4) questionnaires at baseline and 1, 3, 6, and 12 months after treatment. Ten HCC patients with Child-Pugh B liver function were also treated.
Results
The QLQ-C30 was available for 205 patients, and 196 completed the FACT-Hep. No difference in baseline QoL (P=.17) or overall survival (P=.088) was seen between the HCC, liver metastases, and intrahepatic cholangiocarcinoma patients.
Appetite loss and fatigue measured by the QLQ-C30 clinically and statistically worsened by 1 month after treatment but recovered by 3 months. At 3 and 12 months after treatment, respectively, the FACT-Hep score had improved relative to baseline in 13%/19%, worsened in 36%/27%, and remained stable in 51%/54%. Using the QLQ-C30 Global Health score, QoL improved in 16%/23%, worsened in 34%/39%, and remained stable in 50%/38% at 3 and 12 months, respectively.
Median survival was 17.0 months (95% confidence interval [CI] 12.3-19.8 months). Higher baseline scores on both FACT-Hep and QLQ-C30 Global Health were associated with improved survival. Hazard ratios for death, per 10-unit decrease in QoL, were 0.90 (95% CI 0.83-0.98; P=.001) and 0.88 (95% CI 0.82-0.95; P=.001), respectively. Tumor size was inversely correlated with survival.
Conclusions
Liver SBRT temporarily worsens appetite and fatigue, but not overall QoL. Stereotactic body radiation therapy is well tolerated and warrants comparison against other liver-directed therapies.
jueves, 15 de octubre de 2015
Poor-Quality Diets Among Cancer Survivors
Medscape Medical News > Oncology
Poor-Quality Diets Among Cancer Survivors
Veronica Hackethal, MD
October 13, 2015
The diets of many cancer survivors do not meet 2010 dietary guidelines set by the US Department of Agriculture, and many many survivors eat poorer-quality diets, more empty calories, and less fiber than the general population.
The findings come from the first study to look at dietary intake among cancer survivors in a nationally representative sample of US residents. It was published online October 13 in Cancer.
"These findings reinforce the need for dietary intervention in this high-risk population," commented first author Fang Fang Zhang, MD, PhD, of the Friedman School of Nutrition Science and Policy at Tufts University, in Medford, Massachusetts.
"Nutrition is one of the cornerstones for cancer prevention and control. Unfortunately, nutrition is not typically integrated into the delivery of optimal care for cancer patients," Dr Zhang told Medscape Medical News.
Better nutrition could help protect cancer survivors from other chronic illnesses, potentially improving their long-term health and survival, she suggested.
"It is important to note that cancer survivors have significantly higher chronic disease burden than the general population," Dr Zhang highlighted. "Improving diet quality can be a particularly important focus for cancer survivors to achieve a long and healthy life."
Accumulating evidence points to improved survival outcomes in cancer survivors when they meet dietary guidelines compared with those who do not, Dr Zhang pointed out.
Current evidence is limited, however, to major cancer types. Few large-scale intervention studies have evaluated the impact of dietary changes and specific nutrients on cancer recurrence and survival. More research is needed in this area, she noted.
Nationally Representative Sample
Data for the study came from people who participated from 1999 to 2010 in the nationally representative US National Health and Nutrition Examination Survey. Researchers looked at dietary intake and quality in 1533 adult survivors of breast, prostate, colorectal, and lung cancer.
The patients were matched with regard to age, race, and ethnicity to 3075 people who did not have a history of cancer. The investigators evaluated dietary intake using 24-hour dietary recall interviews conducted in person and over the telephone by trained interviewers. Diet quality was assessed using the 2010 Healthy Eating Index (HEI-2010), in which a higher score indicates better adherence to US dietary guidelines.
The majority of cancer survivors were women (66%) and non-Hispanic whites (83%). Results adjusted for age, sex, and race/ethnicity showed that cancer survivors had significantly lower-quality diets compared with participants who did not have a history of cancer (HEI-2010 total score: 47.2 ± 0.5 vs 48.3 ± 0.4, respectively; P = .03).
Cancer survivors ate significantly more empty calories (P = .001) and less fiber (P = .02), which suggests that they got more of their calories from solid fats, alcohol, and added sugars.
The mean dietary intake of certain nutrients in cancer survivors failed to meet federal recommendations: vitamin D (31% of recommended intake), vitamin E (47%), potassium (55%), fiber (60%), and calcium (73%). Survivors also had diets high in sodium (133% of the recommended intake) and saturated fat (112%). Their diets were low in green vegetables and whole grains.
Diet quality improved with age but was worse among those whose education was at the high school level or lower, compared with those with higher levels of education.
Compared with survivors of prostate and colorectal cancer, breast cancer survivors had the highest-quality diets, and lung cancer survivors had the lowest-quality diets (P = .008 and P = .002, respectively).
Current smokers had significantly lower-quality diets than current and former smokers (P < .001). After adjusting for smoking status, results suggested that the differences in diet quality between cancer survivors and those who did not have a history of cancer may be due in part to smoking, suggesting that as a group, smokers are at particularly high risk with regard to dietary interventions. Several other factors could also explain the worse-quality diet in cancer survivors, according to Dr Zhang. Cancer therapies could cause food cravings and/or changes in taste preference. These changes could continue after the end of treatment, making it difficult to follow a healthy diet. Emotional distress during and after treatment could also play a role, she suggested. Finally, cancer patients may already have poor-quality diets at diagnosis, and they may continue this pattern after treatment. "Diets rich in fiber from vegetables, fruits, and whole grains and lower in sodium, solid fats, and added sugars are important dietary targets for cancer survivors," Dr Zhang advised.
"Given the poor diet quality we and others have found in cancer survivors and the high chronic disease burden in this population, it is becoming imperative to routinely integrate nutrition intervention [into cancer care] to improve the health and well-being of cancer survivors across the care continuum," she emphasized.
The authors report no relevant financial relationships.
Cancer. Published online October 13, 2015.
Poor-Quality Diets Among Cancer Survivors
Veronica Hackethal, MD
October 13, 2015
The diets of many cancer survivors do not meet 2010 dietary guidelines set by the US Department of Agriculture, and many many survivors eat poorer-quality diets, more empty calories, and less fiber than the general population.
The findings come from the first study to look at dietary intake among cancer survivors in a nationally representative sample of US residents. It was published online October 13 in Cancer.
"These findings reinforce the need for dietary intervention in this high-risk population," commented first author Fang Fang Zhang, MD, PhD, of the Friedman School of Nutrition Science and Policy at Tufts University, in Medford, Massachusetts.
"Nutrition is one of the cornerstones for cancer prevention and control. Unfortunately, nutrition is not typically integrated into the delivery of optimal care for cancer patients," Dr Zhang told Medscape Medical News.
Better nutrition could help protect cancer survivors from other chronic illnesses, potentially improving their long-term health and survival, she suggested.
"It is important to note that cancer survivors have significantly higher chronic disease burden than the general population," Dr Zhang highlighted. "Improving diet quality can be a particularly important focus for cancer survivors to achieve a long and healthy life."
Accumulating evidence points to improved survival outcomes in cancer survivors when they meet dietary guidelines compared with those who do not, Dr Zhang pointed out.
Current evidence is limited, however, to major cancer types. Few large-scale intervention studies have evaluated the impact of dietary changes and specific nutrients on cancer recurrence and survival. More research is needed in this area, she noted.
Nationally Representative Sample
Data for the study came from people who participated from 1999 to 2010 in the nationally representative US National Health and Nutrition Examination Survey. Researchers looked at dietary intake and quality in 1533 adult survivors of breast, prostate, colorectal, and lung cancer.
The patients were matched with regard to age, race, and ethnicity to 3075 people who did not have a history of cancer. The investigators evaluated dietary intake using 24-hour dietary recall interviews conducted in person and over the telephone by trained interviewers. Diet quality was assessed using the 2010 Healthy Eating Index (HEI-2010), in which a higher score indicates better adherence to US dietary guidelines.
The majority of cancer survivors were women (66%) and non-Hispanic whites (83%). Results adjusted for age, sex, and race/ethnicity showed that cancer survivors had significantly lower-quality diets compared with participants who did not have a history of cancer (HEI-2010 total score: 47.2 ± 0.5 vs 48.3 ± 0.4, respectively; P = .03).
Cancer survivors ate significantly more empty calories (P = .001) and less fiber (P = .02), which suggests that they got more of their calories from solid fats, alcohol, and added sugars.
The mean dietary intake of certain nutrients in cancer survivors failed to meet federal recommendations: vitamin D (31% of recommended intake), vitamin E (47%), potassium (55%), fiber (60%), and calcium (73%). Survivors also had diets high in sodium (133% of the recommended intake) and saturated fat (112%). Their diets were low in green vegetables and whole grains.
Diet quality improved with age but was worse among those whose education was at the high school level or lower, compared with those with higher levels of education.
Compared with survivors of prostate and colorectal cancer, breast cancer survivors had the highest-quality diets, and lung cancer survivors had the lowest-quality diets (P = .008 and P = .002, respectively).
Current smokers had significantly lower-quality diets than current and former smokers (P < .001). After adjusting for smoking status, results suggested that the differences in diet quality between cancer survivors and those who did not have a history of cancer may be due in part to smoking, suggesting that as a group, smokers are at particularly high risk with regard to dietary interventions. Several other factors could also explain the worse-quality diet in cancer survivors, according to Dr Zhang. Cancer therapies could cause food cravings and/or changes in taste preference. These changes could continue after the end of treatment, making it difficult to follow a healthy diet. Emotional distress during and after treatment could also play a role, she suggested. Finally, cancer patients may already have poor-quality diets at diagnosis, and they may continue this pattern after treatment. "Diets rich in fiber from vegetables, fruits, and whole grains and lower in sodium, solid fats, and added sugars are important dietary targets for cancer survivors," Dr Zhang advised.
"Given the poor diet quality we and others have found in cancer survivors and the high chronic disease burden in this population, it is becoming imperative to routinely integrate nutrition intervention [into cancer care] to improve the health and well-being of cancer survivors across the care continuum," she emphasized.
The authors report no relevant financial relationships.
Cancer. Published online October 13, 2015.
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