Wednesday, July 29, 2015

U.S. Oncologists Decry High Cost of Cancer Drugs

They suggest letting Medicare negotiate prices, back grassroots movement calling for change

WebMD News from HealthDay

By Robert Preidt
HealthDay Reporter

THURSDAY, July 23, 2015 (HealthDay News) -- Soaring costs for cancer drugs are hurting patient care in the United States, a group of top oncologists claim.
"High cancer-drug prices are affecting the care of patients with cancer and our health care system," Dr. Ayalew Tefferi, a hematologist at Mayo Clinic in Rochester, Minn., said in a Mayo news release.
Tefferi and his colleagues made a number of recommendations on how to address the problem in a commentary published July 23 in the Mayo Clinic Proceedings.
Allowing Medicare to negotiate drug prices is one of the suggestions the team of 118 leading cancer experts offered as a possible solution.
Along with their recommendations, the group also expressed support for a patient-based grassroots movement on that is demanding action on the issue.
"The average gross household income in the U.S. is about $52,000 per year. For an insured patient with cancer who needs a drug that costs $120,000 per year, the out-of-pocket expenses could be as much as $25,000 to $30,000 -- more than half their average household income," Tefferi explained in the news release.
A study published earlier this year in the Journal of Economic Perspectives found that cancer drug prices have increased an average of $8,500 a year over the past 15 years.
"When you consider that cancer will affect one in three individuals over their lifetime, and [with] recent trends in insurance coverage [that] put a heavy financial burden on patients with out-of-pocket expenses, you quickly see that the situation is not sustainable," Tefferi said. "It's time for patients and their physicians to call for change."
The changes the commentary called for included:
  • Create a review mechanism after a drug has been approved by the U.S. Food and Drug Administration that would propose a fair price for new cancer drugs that is based on the value to patients and health care.
  • Allow the Patient-Centered Outcomes Research Institute -- established under the Affordable Care Act -- to evaluate the benefits of new cancer therapies, and let similar organizations include drug prices in their assessments of a treatment's value.
  • Permit patients to import cancer drugs from other countries. For example, prices in Canada are about half that of prices in the United States, the experts said.
  • Pass legislation to prevent drug companies from delaying the introduction of generic drugs, and reform the patent system to make it more difficult to unnecessarily extend patent protection of a drug.
  • Encourage groups that represent cancer specialists and patients to consider the overall value of drugs and treatments when developing their treatment guidelines.
The group wrote that "it should be possible to focus the attention of pharmaceutical companies on this problem and to encourage our elected representatives to more effectively advocate for the interests of their most important constituents among the stakeholders in cancer -- American cancer patients."



Circulating BRAF may aid in papillary thyroid cancer diagnosis, follow-up

FDA Grants Breakthrough Designation to Lenvatinib for Renal Cell Carcinoma

Studies continue to assess lenvatinib for patients with RCC, including a phase I investigation of the combination of lenvatinib and everolimus in patients with unresectable advanced RCC (NCT02454478). Additionally, a phase Ib/II study is exploring lenvatinib in combination with the PD-1 inhibitor pembrolizumab (Keytruda) for patients with solid tumors, including RCC (NCT02501096). - See more at:

Silas Inman
 This article includes some discussion of using Lenvatinib for Thyroid Cancer.
Silas Inman

The FDA has granted a breakthrough therapy designation to lenvatinib (Lenvima) as a potential treatment for patients with advanced renal cell carcinoma (RCC) who have received a VEGF-targeted therapy, according to a statement from Eisai, the company developing the multikinase inhibitor.

The designation was based on findings from an open-label three-arm phase II study that demonstrated an improvement in progression-free survival (PFS) for lenvatinib compared with everolimus (Afinitor) in patients with advanced RCC. In findings presented at the 2015 ASCO Annual Meeting, lenvatinib monotherapy improved PFS by 39% versus everolimus monotherapy (HR = 0.61; 95% CI, 0.38-0.98; P = .048). Additionally, the combination of lenvatinib and everolimus demonstrated a 60% improvement in PFS over everolimus alone (HR = 0.40; 95% CI, 0.24-0.68; P <.001).

"We are excited and honored that the FDA has granted breakthrough therapy designation to lenvatinib for patients with metastatic renal cell carcinoma," Kenichi Nomoto, PhD, president, Oncology Product Creation Unit at Eisai, said in a statement. "We look forward to working closely with the FDA to expedite this clinical program and hope to offer an important additional treatment option to patients in need."

In the phase II open-label study, 153 patients were randomized in a 1:1:1 ratio to lenvatinib (18 mg/day) plus everolimus (5 mg/day), lenvatinib monotherapy (24 mg/day) or everolimus monotherapy (10 mg/day). No crossover was permitted within the context of the study. The primary endpoint of the study was to compare PFS in the lenvatinib arms with single agent everolimus.

The most common prior VEGF therapy received by patients in the trial was sunitinib, at 71%, 67%, and 56% in the combination, lenvatinib, and everolimus arms, respectively. The remaining patients had received either pazopanib or sorafenib. Thirteen percent of patients had received a prior cytokine or checkpoint inhibitor therapy, at 10%, 8%, and 14%, in the combination, lenvatinib, and everolimus arms, respectively.

The median PFS was 14.6 months for lenvatinib plus everolimus (n = 51), 7.4 months for lenvatinib alone (n = 52), and 5.5 months for everolimus (n = 50). The ORR in the combination arm was 43%, with lenvatinib it was 27%, and with everolimus it was 6%.

The median overall survival (OS) was 25.5 months in the combination arm, 19.1 months in the lenvatinib monotherapy arm, and 15.4 months in the single-agent everolimus arm. The combination of lenvatinib and everolimus reduced the risk of death by 49% compared with everolimus alone (HR = 0.51; 95% CI, 0.30-0.88; P = .024). Single-agent lenvatinib improved OS by 32% versus single-agent everolimus (HR = 0.68; 95% CI; 0.41-1.14); however this was not statistically significant (P = .118).

All patients experienced at least one treatment-emergent adverse event (AE) in each treatment arm. Treatment-related grade 3 AEs occurred in 71% of patients in the combination arm, 83% in the single-agent lenvatinib arm, and 52% in the everolimus arm. There were relatively few grade 4 events in any of the three arms.

Diarrhea was the most frequently occurring all-grade AE in the lenvatinib arms, at 84% in the combination arm and 71% with monotherapy. Grade 3 diarrhea occurred in 20% of patients in the combination arm compared with 12% for single-agent lenvatinib and 2% with everolimus. Outside of diarrhea, other common grade ≥3 AEs with the combination included hypertension (14%) and fatigue (10%).

"The high-response rate and the longer OS results speak to the high-level of efficacy observed in the study for the combination," lead investigator Robert Motzer, MD, an attending physician, Memorial Sloan Kettering Cancer Center, said when the findings were presented. "Adverse events were generally higher for the lenvatinib-containing arms compared with everolimus. These adverse events were predictable, and generally managed with dose modifications."

Dose reductions were required in 73% of patients treated the combination, 62% treated with single-agent lenvatinib, and for 26% in the everolimus alone arm. AEs were the cause of treatment discontinuation for 9%, 11%, and 5% of patients in the combination, single-agent lenvatinib, and everolimus arm, respectively.

The FDA initially approved Lenvatinib as a treatment for patients with progressive, radioactive iodine-refractory differentiated thyroid cancer in February 2015. The FDA's breakthrough therapy designation will help further expedite the development of the therapy for patients with advanced RCC.

Studies continue to assess lenvatinib for patients with RCC, including a phase I investigation of the combination of lenvatinib and everolimus in patients with unresectable advanced RCC (NCT02454478). Additionally, a phase Ib/II study is exploring lenvatinib in combination with the PD-1 inhibitor pembrolizumab (Keytruda) for patients with solid tumors, including RCC (NCT02501096).
- See more at:
Silas Inman @silasinman
Published Online: Tuesday, July 28, 2015
- See more at:
Silas Inman @silasinman
Published Online: Tuesday, July 28, 2015
- See more at:

Studies continue to assess lenvatinib for patients with RCC, including a phase I investigation of the combination of lenvatinib and everolimus in patients with unresectable advanced RCC (NCT02454478). Additionally, a phase Ib/II study is exploring lenvatinib in combination with the PD-1 inhibitor pembrolizumab (Keytruda) for patients with solid tumors, including RCC (NCT02501096). - See more at:
Silas Inman @silasinman
Silas Inman @silasinman
Published Online: Tuesday, July 28, 2015
- See more at:

TERT promoter mutations indicate poor outcomes in differentiated thyroid cancer | Endocrinology

TERT promoter mutations indicate poor outcomes in differentiated thyroid cancer | Endocrinology:

Melo M. J Clin Endocrinol Metab. 2014;doi:10.1210/jc.2013-3734.
Telomerase reverse-transcriptase promoter mutations could be a major indicator of tumor aggressiveness in differentiated thyroid carcinomas. In a retrospective observational study, they were associated with distant metastases, poor response to treatment and outcomes.

The study included 647 tumors and tumor-like lesions in 469 patients with follicular cell-derived thyroid carcinomas treated and followed in five university hospitals.
The telomerase reverse-transcriptase (TERT) promoter mutations were observed in 7.5% of papillary carcinomas (PTC), 17.1% of follicular carcinomas (FTC), 29% of poorly differentiated carcinomas (DTC) and 33.3% of anaplastic thyroid carcinomas, according to data.
“The detection of such mutations appears to be, per se, a promising prognostic indicator in DTC and PTC,” researchers wrote.
In the group with DTC, TERT-mutated tumors were associated with older age (P<.001) and larger tumors (P=.002). In addition, TERT promoter mutations were significantly associated with distant metastases (P<.001) and higher stage (P<.001), researchers wrote.
Patients with DTC and TERT promoter mutations tended to be exposed to more radioiodine treatments (P=.009) with a greater cumulative dose (P=.004), and administered more treatment modalities (P=.001), researchers wrote.
“The most important added value of the present study is that we found evidence showing that patients with TERT mutated tumors had decreased survival when compared with patients with tumors harboring wild-type TERT and, moreover, that this holds true for the whole DTC series, as well as for PTC and FTC independently,” researchers wrote.
At 7.8 years follow-up, researchers found that patients with TERT-mutated DTC were more likely to display persistent disease (P=.001); TERT promoter mutations were significantly associated with disease-specific mortality among patients with follicular cell-derived thyroid carcinomas (P<.001), DTC (P<.001), PTC (P=.001), and FTC (P<.001).
After adjustments for age at diagnosis and sex, researchers wrote that the HR was 10.35 (95% CI, 2.01-53.24) in DTC and 23.81 (95% CI, 1.36-415.76) in PTC.
“Our findings suggest a link between telomerase activity and metastatic capacity may exist,” researchers wrote.
Disclosure: The researchers report no relevant financial disclosures.

Tuesday, July 28, 2015

Aggressive hormone suppression unnecessary in most thyroid cancers

Thyroid Cancer?: When Testing vs. Surgery Makes a Whole Lot More Sense

Written by

The number of thyroid surgeries for suspected cancer has dramatically risen in recent years, and several new molecular thyroid cancer tests may be able to slow the trend. The total number of thyroid surgeries performed in the United States due to suspicious thyroid nodules increased from 99,613 to 130,216 between 2006 and 2011, according to a 2013 study. But experts believe many thyroid surgeries are performed unnecessarily.

Thyroid cancers are often slow growing and many don’t grow much at all and never become harmful. In addition, ambiguous results from fine needle biopsies, the first line of testing, contribute to the overuse of surgical biopsies.

Cancer in the thyroid, which is located in the lower area of the neck, is the fifth most common cancer diagnosed in women. But many of these cancers may never be problematic if left alone.

The American Thyroid Association is updating their 2009 guidelines for the management of thyroid cancer in an effort to rein in the surgeries and provide more appropriate care. The guidelines, which will be published this fall, will reference a statement on the use of molecular tests for thyroid nodules that are considered ambiguous.
Thyroid nodules are extremely common, but patients with thyroid nodules that grow to 1 to 2 cm., depending on other characteristics and risk factors, often have a needle biopsy to test for cancer, explains Robert Ferris, MD, PhD, professor and chief of the Division of Head and Neck Surgery in University of Pittsburgh School of Medicine.
The biopsied tissue is then classified as benign or cancerous, but about 20 to 30 percent are classified as “indeterminate.” Those patients with uncertain results are often told to surgically remove the thyroid or have a partial surgery, or lobectomy, to be on the safe side. But the new molecular tests can determine if a nodule is low risk and unlikely to grow to the size to cause problems.

Looking to Molecular Testing

“Minimally invasive molecular testing for thyroid cancer has improved by leaps and bounds in the last several years,” said Dr. Ferris, who is co-author of the new statement regarding molecular testing.

One of the commercially available tests, called the Afirma test, can rule out cancer with a high rate of accuracy on indeterminate tests. It looks at the levels of expression of 142 genes and can predict low risk nodules.  “If the test result is ‘likely benign,’ a patient can avoid getting surgery,” says Dr. Ferris.
Another test developed by the University of Pittsburgh, called ThyroSeq v2.0, allows pathologists to simultaneously test for multiple genetic markers of thyroid cancer. It looks at mutations of up to 60 single base oncogenes, which are thought to turn on the growth of the nodule and cause malignant behavior, explains Dr. Ferris. This test can not only rule out non-cancerous nodules, but it can also accurately identify cancers with 80 to 100% accuracy. In the future, the test will likely help differentiate between very high risk malignancies that would require surgery and low-risk malignancies which could take more of a wait and see approach.

A common approach today for someone with a suspicious nodule or a small thyroid cancer that shows no signs of spread beyond the thyroid gland is to have a lobectomy, the removal of the right or left lobe where the nodule is located, sparing the rest of the thyroid. If the biopsy is then graded as high risk, the patient would go back in for a second surgery to remove the rest of the thyroid. The ThyroSeq v2.0 can help people avoid that two step process by assessing the risk of the tumor from the needle biopsy sample. “The Pittsburgh test can determine if you have an 80 to 100% risk of cancer and can offer the patient a total thyroidectomy up front, to avoid two surgeries,” Dr. Ferris says.

“Thousands of thyroidectomies could be avoided and thousands of two-step procedures could be avoided every year if we adapted these tests,” he says. “We need to educate the doctors out there that these molecular tests are valuable.”

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Sunday, July 26, 2015

Singer beats cancer to regain voice

Singer beats cancer to regain voice: Brave Helen shares her story

SINGING has taken the Booyal local Helen Coleman around Australia and the world, but the woman from the Childers area has had to overcome cancer to regain her voice.
Ms Coleman now resides in the Scenic Rim area where she can focus on her amazing talent.
The talented soprano soloist started with humble beginnings with her piano and singing teacher Mrs Cunningham.
Mrs Cunningham, also a soprano, trained in London and retired to Childers, and saw talent in Helen as a young performer.
Ms Coleman is influenced by jazz, blues and gospel music.
Ms Coleman said it wasn't all smooth sailing.
Her career was hit with a hard blow when she was diagnosed with thyroid cancer in 2012.
"My biggest fear was I was never going to sing again," she said. 
The surgery resulted in her losing her voice completely.
Many friends from the singing community rallied around to show support in her time of need. "I really thought I would never sing or speak again, so I focused on my horses," she said.
Ms Coleman said that for 12 months after the surgery, "no words passed my lips".
It was during this time that Ms Coleman came to realise the infinite healing power of music.
"I have now spent two years working very hard to get my voice back," she said.
Her support and training has resulted in gaining her full voice once again.
Ms Coleman has recorded her debut album and it is due to be released this year.
"I want to be a positive influence on young artists and I hope my struggle can help others," she said.