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Prescription Cancer Drugs

Physical Therapists Play Integral Role In Prevention, Risk Reduction, And Treatment Of Painful And Often Irreversible Side Effect Of Cancer Treatment

Posted by: admin in Prescription Cancer Drugs on June 29th, 2010

As breast cancer awareness month is observed during October, the American Physical Therapy Association (APTA) is hoping to shine a spotlight on lymphedema, a chronic, debilitating and often irreversible side effect of cancer treatment. According to APTA, breast cancer patients who seek the services of a physical therapist can reduce their risk of lymphedema, as it can be prevented or more effectively managed if caught in its earliest stages and treated by a physical therapist. APTA is launching this effort as it kicks off National Physical Therapy Month in October to educate the public about the important role physical therapists and physical therapist assistants play in health care.

Breast cancer-related lymphedema, which can cause significant swelling of the upper and lower extremities due to the build-up of excess lymph fluid, is mostly caused by damage to the body’s lymphatic system during treatment for cancer and can include limited movement, joint pain, and difficulty performing activities. Physical therapists, who are experts in restoring motion and mobility in people’s lives, play an important role not only in treating the effects of lymphedema but also in reducing the risk of occurrence.

A study published in the journal Cancer (April 25, 2008) showed that pre-operative assessments of patients with breast cancer by physical therapists allow for earlier diagnosis and treatment of lymphedema. This includes programs that use infra-red technology to measure limb volume and regular post-operative follow-up to detect lymphedema.

The study further demonstrated that when lymphedema was detected early, the patient’s condition was managed with a more conservative approach that included a light-grade compression sleeve and hand gauntlet that effectively decreased early swelling and possibly prevented the progression of lymphedema. Fitted by a physical therapist, these were prescribed for daily wear.

“Lymphedema is normally treated with more aggressive and often costly and time-consuming techniques, such as complete decongestive therapy,” explained APTA Board member and spokesperson, and the study’s lead author, Nicole Stout, PT, MPT, CLT-LANA. Complete decongestive therapy requires the patient to attend daily therapy sessions for weeks and wear bulky compression bandages.

“This study clearly demonstrates the fact that lymphedema can be managed with a more conservative treatment option when diagnosed in its earliest stages, which is good news for patients with breast cancer,” Stout said. “Based on these findings, we encourage patients with breast cancer to seek referral for physical therapy services before, during, and after breast cancer treatment because arm problems can occur at any time during the course of care and the best outcomes are reached when they can be detected early, or even prevented.

“We hope physicians, surgeons, oncologists, and other physical therapists will make early intervention and conservative treatment of lymphedema the standard of care in breast cancer treatment,” Stout concluded.

APTA Board member Babette Sanders, PT, MS, knows firsthand the benefits of using physical therapy for prevention and maintenance of keeping lymphedema at bay. “Swelling occurred immediately in my upper arm and trunk after my mastectomy,” she said. “By quickly incorporating physical therapy as part of my overall management of the condition, I was able to get rid of the swelling and have since kept it away. I am able to remain lymphedema free with monthly preventative treatment. It makes a tremendous difference in the quality of my daily living and my ability to move and function.”

Stout recommends patients with breast cancer be aware of their risk factors and indicators of the onset of lymphedema:

Risk Factors

- Being overweight or gaining weight during or after cancer treatment
- Having lymph nodes removed
- Having radiation therapy
- Having an infection or blood clot in the limb affected by cancer treatment

Warning Signs

- Aching or heaviness in the limb that was affected by cancer treatment
- A feeling of fullness or tightness in the limb affected by cancer treatment
- Visible swelling that affects the limb affected by cancer treatment

Some risk factors, such as the necessary treatment for cancer, cannot be avoided. However, there are many that can be controlled. Maintaining a healthy body weight, proper skin care and hygiene, and avoiding infections from cuts, burns, or skin wounds are all steps you can take to protect your limb. Exercising sensibly and avoiding unnecessary strain to the limb can also help reduce the risk of developing lymphedema. A physical therapist will create an exercise program tailored to your individual needs and monitor its effect on your limb.

Source
American Physical Therapy Association

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ASTRO: Modest Benefit Seen with Decongestive Therapy (CME/CE)

Posted by: admin in Prescription Cancer Drugs on May 28th, 2010

  • Explain to patients that massage therapy and bandaging plus a compression sleeve and glove did not significantly reduce lymphedema associated with breast cancer therapy compared with the compression devices alone.
  • Note, however, that the data suggest that patients with longstanding lymphedema (>1 year) might benefit from decongestive therapy.
  • Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered preliminary until published in a peer-reviewed journal.

CHICAGO — Breast cancer patients with treatment-related lymphedema derived only a modest benefit from decongestive lymphatic therapy compared with a compression sleeve, results of a randomized multicenter Canadian study showed.

The massage-based decongestive therapy reduced fluid volume by less than 7% compared with a compression sleeve, a difference that did not achieve statistical significance.

However, the absolute difference between groups exceeded 100 ml, which gave decongestive therapy a significant advantage over the sleeve (P=0.02).

Women with longstanding lymphedema appeared to benefit most from decongestive therapy, said Ian Dayes, MD, of McMaster University in Hamilton, Ont.

“These results would suggest that there is a modest further reduction in absolute volume in those patients who received massage and bandaging compared with those patients who received elastic sleeve alone,” Dayes said here at the American Society for Radiation Oncology.

“There certainly seems to be more relative benefit in those patients who have longstanding lymphedema as compared with those patients who had lymphedema for less than a year.”

Despite extensive clinical experience with decongestive therapy, the treatment had never been evaluated in a randomized clinical trial.

To address that shortcoming, investigators at six Canadian centers enrolled 103 patients who had lymphedema following completion of breast cancer therapy. Eligible patients had at least a 10% difference in volume between the affected and contralateral arm.

Eight patients withdrew consent, and the remaining 95 had an imbalance in randomization, as 56 patients were assigned to decongestive therapy and 39 to the compression sleeve.

Decongestive therapy consisted of daily one-hour massage by a licensed therapist, continuing for four weeks. The patients wore gauze and bandages for the remaining 23 hours a day. After completing the massage therapy, patients were fitted for an elastic compression sleeve and glove, which they wore for 12 hours a day. They also received advice on skin care, exercise, and diet.

Control therapy consisted of the compression sleeve and glove and advice about skin care, exercise, and diet.

The primary outcome was the change in volume of the treated arm at the end of decongestive therapy, calculated from circumferential measurements.

The contralateral arm was used for comparison. Measurements were obtained at baseline, during and after treatment, and at weeks 12, 24, and 52. Secondary outcomes included absolute change in arm volume in milliliters, quality of life, and arm function as assessed by a standardized instrument.

At baseline, excess arm volume averaged 684 mL (27%) for all 103 patients, 698 mL (27%) for the 95 evaluable patients, 751 mL (29%) in patients assigned to decongestive therapy, and 624 mL (24%) in the control group.

At the study’s completion, reduction in arm volume averaged 29.3% in the experimental group and 22.6% in the control group (P=0.32). The absolute reduction averaged 252 mL with decongestive therapy and 143 mL in the control group, a difference that achieved statistical significance (P=0.02).

A prespecified analysis of the results by duration of lymphedema also revealed a statistically significant absolute difference.

Among patients with lymphedema for less than a year, the absolute reduction in arm volume averaged 150 to 200 mL in both groups. However, women with lymphedema for a year or longer had a mean volume reduction of 320 to 330 mL with decongestive therapy versus a little more than 100 mL with the compression devices alone (P=0.02).

Scores on assessments of quality of life and arm function did not change significantly in either group and did not differ between groups.

Dayes said data from long-term follow-up will be analyzed and reported in the future.

Dayes and co-investigators had no disclosures.

Primary source: American Society for Radiation Oncology

Source reference:
Dayes I, et al “DELTA: a randomized trial of decongestive lymphatic therapy for women with lymphedema following treatment for breast cancer” ASTRO 2009; Abstract 112.


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ASTRO: Breast Brachytherapy Use Outpaces Evidence (CME/CE)

Posted by: admin in Prescription Cancer Drugs on May 24th, 2010

  • Explain to patients that the use of a limited form of radiation therapy to treat breast cancer has increased in recent years.
  • Note that a limited amount of data from large clinical trials has validated the safety and efficacy of breast brachytherapy.
  • Note, too, that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

CHICAGO — Use of brachytherapy to treat breast cancer continues to increase despite unresolved questions about long-term outcomes, according to data presented here.

From 2001 through 2006, breast brachytherapy accounted for 5% of all radiation therapy administered to a cohort of more than 6,000 postmenopausal breast cancer patients. However, in the years after 2004 — when Medicare began reimbursing for the modality — use of the modality more than doubled, to 10% in the first half of 2006.

The findings strongly suggest that nonclinical factors will determine breast brachytherapy’s role in coming years.

“Despite ongoing debate over long-term outcomes, breast brachytherapy has been rapidly incorporated into treatment of breast cancer,” Thomas A. Buchholz, MD, of the University of Texas M. D. Anderson Cancer Center in Houston, said here at the American Society for Radiation Oncology meeting.

“The availability of clinical evidence is less likely to be a major force in determining the diffusion of this new technology. Instead, nonclinical factors — such as public policy and socioeconomic factors — are likely to play an important role.”

The efficacy of whole-breast irradiation after conservative surgery has been demonstrated in Phase III clinical trials involving 60,000 to 100,000 patient-years of follow-up, said Buchholz. In contrast, Phase III data of partial breast irradiation with brachytherapy has yet to mature and comprises about 1,500 patient-years of follow-up.

The lack of supporting data for breast brachytherapy has created controversy regarding use of the radiation modality, he added.

Access to a nationwide database of Medicare beneficiaries with private supplemental insurance provided an opportunity to examine the use of breast brachytherapy and the factors associated with its use.

Buchholz and his colleagues identified 6,882 women ages 65 and older with newly diagnosed breast cancer from 2001 through 2006. The database provided access to information about inpatient, outpatient, and prescription claims.

All of the patients had breast-conserving surgery followed by radiation therapy — external-beam radiation, brachytherapy, or a combination of the two modalities.

Patients had a mean age of 75, 8% had axillary involvement, and 4% had metastatic disease. Buchholz said that 78% of the cohort had axillary dissection, 10% had chemotherapy, and 65% received endocrine therapy.

Overall, external-beam radiation therapy accounted for 95% of all radiotherapy administered to the patients. Fewer than 1% received both external-beam radiation and brachytherapy, and the remaining patients had brachytherapy as the sole form of radiotherapy.

Trend analysis showed that use of brachytherapy remained stable at about 1% of cases from 2001 to the first half of 2002, when the FDA approved the therapy. Use of brachytherapy increased to about 3% of cases in the second half of 2002 and remained at that level until the first half of 2004, when Medicare started covering brachytherapy.

Brachytherapy continued to account for about 4% of all radiation therapy used to treat breast cancer through 2004, then increased to more than 6% of cases in the first half of 2005, 8% in the second half of 2005, and 10% during the first six months of 2006.

Analysis of clinical factors associated with use of brachytherapy revealed three significant predictors:

  • Node-negative disease (OR 2.19, 95% CI 1.17 to 4.11)
  • Axillary surgery (OR 1.72, 95% CI 1.28 to 2.44)
  • No chemotherapy (OR 1.68, 95% CI 1.01 to 2.80)

Examination of nonclinical factors such as geography, type of healthcare system, income, and availability of radiation oncologists and surgeons all influenced the use of brachytherapy.

Using the northeast region of the U.S. as reference, Buchholz and colleagues found increased use of breast brachytherapy in western states (OR 2.83), in the South (2.36), and in the Midwest (OR 1.62).

Treatment by non-HMO providers also was associated with increased use of brachytherapy (OR 1.81).

A higher median income made use of brachytherapy more likely (OR 1.58), as did a low density of radiation oncologists in an area (1.78) and a high density of surgeons (OR 2.36).

The authors had no disclosures.

Primary source: American Society for Radiation Oncology

Source reference:
Smith GL, et al “Breast brachytherapy in the U.S.: Utilization patterns in older patienets after breast-conserving surgery” ASTRO 2009; Abstract 164.


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ASCO: Conflicting Data on Breast Cancer, Tamoxifen, SSRIs (CME/CE)

Posted by: admin in Prescription Cancer Drugs on September 05th, 2009

ORLANDO, May 30 — If breast cancer survivors hoped to learn whether the antidepressants they’re taking interfere with tamoxifen’s ability to prevent a cancer recurrence, they were disappointed here this weekend. One major study said “yes” and another said “no.”

  • Explain to patients that two studies produced conflicting evidence about certain drugs’ effect on tamoxifen’s ability to prevent breast cancer.
  • Both studies were based on a review of medical records, not a prospective clinical trial.
  • Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

A review of medical records involving almost 1,000 U.S. breast cancer patients showed that concomitant use of tamoxifen and drugs that inhibit the CYP2D6 pathway doubled the risk of recurrence in the first two years after starting tamoxifen, according to one report delivered at the annual meeting of the American Society of Clinical Oncology.

Among the best-known antagonists of CYP2D6 are certain members of the selective serotonin reuptake inhibitor (SSRI) class of antidepressants, which are widely used to prevent tamoxifen-induced hot flashes.

“Our findings support the presence of a clinically significant drug interaction between tamoxifen and known CYP2D6 inhibitors,” Ronald E. Aubert, Ph.D., of Medco Health Solutions in Franklin Lakes, N.J., and colleagues concluded.

In contrast, Dutch investigators reported just the opposite: they found no evidence that CYP2D6 inhibitors increase the risk of breast cancer recurrence in women taking tamoxifen.

However, they did show that poor adherence to tamoxifen therapy reduces breast cancer event-free survival, which they said had not been shown previously.

“This is a very important topic because obviously we have thousands of women who are on tamoxifen, and CYP2D6 is the most important enzyme in the metabolism of tamoxifen,” said breast cancer specialist Lori Pierce, M.D., of the University of Michigan, who was not involved in either study.

“We still have a lot of work to do,” she added. “These two conflicting studies show that we still don’t have a definite answer about how important CYP2D6 function is. We need to do more validative studies to find out whether or not we should be testing women [for CYP2D6 status] who are on tamoxifen.”

As Dr. Pierce noted, CYP2D6 is essential for the breakdown of tamoxifen to the active metabolite endoxifen. Studies have shown that women with genetic mutations that block the synthesis of the CYP2D6 enzyme do not get the same cancer-prevention benefits from tamoxifen as women who have a normal gene.

Studies also have suggested that drugs that interfere with the CYP2D6 pathway reduce blood levels of endoxifen in women taking tamoxifen. Two of the most commonly used CYP2D6 inhibitors are the SSRI antidepressants fluoxetine and paroxetine, which many women take to prevent hot flashes while on tamoxifen.

To determine whether drug-induced CYP2D6 inhibition adversely affects breast cancer outcomes, Dr. Aubert and colleagues reviewed medical and pharmacy records for 10.7 million members of U.S. healthcare plans. They searched for breast cancer patients who started tamoxifen during a 30-month period from 2003 to 2005.

The data analysis revealed 1,298 women, 945 who took tamoxifen alone and 353 who took a CYP2D6 inhibitor at the same time they were on tamoxifen.

The study showed a two-year breast cancer recurrence rate of 13.9% in women taking tamoxifen and a CYP2D6 inhibitor compared with a 7.5% recurrence rate among women taking tamoxifen alone. The difference translated into hazard ratio for recurrence of 1.92 for the CYP2D6 group compared with the tamoxifen-only group (95% CI 1.33 to 2.76, P<0.001).

The Dutch study had a similar design, as investigators reviewed pharmacy data on 1,962 breast cancer patients treated with tamoxifen from 1994 to 2006. Of those, 150 women took a CYP2D6 inhibitor for 60 days or longer while on tamoxifen.

During 4.1 years of follow-up, the CYP2D6 group had a recurrence rate of 13.3% compared with 14.6% among women who took tamoxifen alone or took a CYP2D6 inhibitor for less than 60 days while on tamoxifen.

“Based on our findings and previous studies, we don’t have strong evidence that it’s unsafe to use 2D6 inhibitors during tamoxifen therapy,” Vincent Dezentje, M.D., of Leiden University Medical Center, said in a statement.

“But because the number of patients on both tamoxifen and 2D6 inhibitors was small in our study, our findings will need to be confirmed in larger trials. Until a link between 2D6 inhibitors can be definitively confirmed, doctors and patients should be cautious about using these drugs together.”

The study confirmed the suspicion that poor adherence to tamoxifen adversely affected event-free survival. Though seemingly intuitive, the association had not been demonstrated previously, according to the investigators.

Until the issue is resolved, women taking tamoxifen have alternatives to CYP2D6 inhibitors to prevent hot flashes, said Dr. Pierce, noting that not all SSRIs inhibit the enzyme. Using an aromatase inhibitor instead of tamoxifen to prevent breast cancer recurrence is another possible option.

“You should make the best judgment in terms of the appropriate medication for the patient, given her disease,” said Dr. Pierce. “There are ways to work around the problem if tamoxifen is the best drug for a patient. But certainly aromatase inhibitors are very important drugs in our armamentarium for postmenopausal women with breast cancer.”

One or more investigators in the U.S. study disclosed financial relationships with LabCorp, Medco Health Solutions, Roche Molecular Diagnostics, and Roche Molecular Solutions.

Investigators in the study included Medco employees. Investigators in the Dutch study reported no disclosures.

Primary source: Journal of Clinical Oncology

Source reference:
Aubert, RE et al “Risk of breast cancer recurrence in women initiating tamoxifen with CYP2D6 inhibitors” J Clin Oncol 2009; 27(15S): Abstract CRA508.

Additional source: Journal of Clinical Oncology

Source reference:
Dezentje V, et al “Concomitant CYP2D6 inhibitor use and tamoxifen adherence in early-stage breast cancer: a pharmacoepidemiologic study” J Clin Oncol 2009; 27(15S): Abstract CRA509.

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Researchers Find Clues To Improve Breast Cancer Survival

Posted by: admin in Prescription Cancer Drugs on June 10th, 2009

Checking lymph nodes during surgery and assessing the hormone status of tumours could help improve breast cancer survival in the UK, according to research published today in Annals of Oncology.

In a study of over 9,000 breast cancer patients* at 10 hospitals in the East of England researchers found that hospitals with a better average survival were those where surgeons checked lymph nodes during surgery in more than 90 per cent of patients.

Professor Stephen Duffy, Cancer Research UK professor of screening and study author, said: “We found that the proportion of women under 70 who had lymph node checks as recommended by NICE ranged from 81 per cent to 94 per cent with the hospitals with higher percentages having better survival.”

The study also found that, for women over 70, having surgery to remove their tumour and checking the hormone type were the two main factors which explained survival differences between hospitals.

The hospitals showing better survival in the over 70s were those which assessed the hormone receptor status in more of their patients.

The team of researchers** from London and Cambridge compared breast cancer survival rates between 10 different hospitals across eastern England.

For women under 70 the five year relative survival rates ranged from 85 to 90 per cent. And for those over 70 the survival rate was between 65 and 75 per cent.***

The figures are close to the highest rates in Europe**** but the researchers believe that survival could be even better if all hospitals closely followed the existing surgical guidelines.

Professor Duffy continued: “Although survival rates for breast cancer are very good in hospitals we studied in the East of England, rivalling the best in Europe, we have found that there is still room for improvement.

“One reason why survival varied between the hospitals for women under 70 was whether they had their lymph nodes removed and examined. Another is screening as we know from previous studies that women have a much better chance of survival if their tumour is picked up at an early stage. We would encourage all women to attend screening when invited.”

The researchers also found that more women older than 70 are surviving the disease if they have surgery. Another important factor for this group of women was whether the cancer’s hormone type was assessed at diagnosis. The researchers believe that with more hospitals following the guidelines on hormone receptor typing, there would be further improvements in survival.

Professor Gordon Wishart, the leading author on the study said: “Lymph node staging and hormone receptor typing give valuable information to decide on optimal treatment after surgery. As more hospitals follow current professional guidelines and carry out these investigations, more effective treatment will follow and patient survival is likely to improve even further.”

Professor Peter Johnson, Cancer Research UK’s chief clinician, said: “It’s very encouraging to see that at their best, results from the UK are the equal of those in Europe. The real challenge is to make sure that consistently high standards are met in all hospitals, so that every patient can benefit from the significant improvements in survival we have made.”

Notes

*All women had been diagnosed with breast cancer between 1999 and 2003.

**The team of researchers included Dr Clement Brown of the Eastern Cancer Registration and Information Centre and Professor Gordon Wishart, the lead author on the study.

***These figures are relative survival rates calculated from overall rates in the paper.

****Figures compared to the Eurocare study Comparative cancer survival information in Europe. Eur J Cancer. 2009 Apr;45(6):901-8.

Source
Cancer Research UK

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| Copyright 2009 |
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