Chemotalk Newsletter

Chemotalk Newsletter, Vol. 109 May 1, 2017

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Hello, out there, and welcome to May.  While I recognize that some of the technical information in these pieces is way over our heads - it's certainly over mine - there is enough pertinent information for non-professionals to help us explain our conditions or the conditions of those we care about.

FDA CRACKS DOWN ON UNAPPROVED DIRECT-TO-CONSUMER CANCER 'CURES'

By Bryant Furlow

The US Food and Drug Administration (FDA) has sent warning letters to 14 companies marketing dozens of unapproved "miracle cure" products online with fraudulent claims that they prevent or cure cancer, the agency announced.

The products the FDA determined to be illegally advertised as cancer treatments ranged from deer antler powder and vitamin C to numerous herbal or plant products. They were advertised and sold primarily on health-oriented websites.

"We encourage people to remain vigilant whether online or in a store, and [to] avoid purchasing products marketed to treat cancer without any proof they will work," cautioned Douglas W. Stearn, JD, the director of the FDA's Office of Enforcement and Import Operations in Rockville, Maryland, in a press release.

Among claims that the FDA determined to be violations of the federal Food, Drug, and Cosmetic Act were claims that unapproved products were nontoxic alternatives to CHEMOTHERAPY, "dissolved" tumors. Many of the products were marketed as curing a wide range of diseases, including cancers, autoimmune diseases, and infections‹including drug-resistant tuberculosis and Ebola virus.

One herbal salve was advertised as having been "designed to help those with cancer sores" and warts, and as a treatment for skin cancer, according to an FDA warning letter. That company marketed the salve on Facebook and Amazon. Reached by phone, the owner said that he had discovered the salve by curing himself of a self-diagnosed mouth tumor. He said that he had made changes to one of his company website's health claims, removing statements about cancer, but that he had not yet changed his product's Amazon.com site or another company website that was not named in the FDA warning letter.

The FDA demanded corrective action plans from the 14 companies and warned that continued violations will trigger "legal action, including product seizure, injunction, and/or criminal prosecution."

Unsafe products previously taken off the market following FDA enforcement actions have reappeared online because companies simply moved their marketing operations to new websites, the agency noted. Consumer education is therefore key to protecting patients from fraudulent cancer "cures."

The FDA asked that healthcare professionals report adverse events associated with the use of such products to its MedWatch program. The agency also offers an online list of fraudulent cancer "cures" and treatments that consumers should avoid.

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BLINGATUMOMAB ACTIVE IN Ph+ B-PRECURSON ACUTE LYMPHOBLASTIC LEUKEMIA

By Leah Lawrence

Single-agent use of the T-cell engager antibody blinatumomab resulted in anti-leukemic activity in patients with tyrosine kinase inhibitor (TKI)-relapsed or refractory Philadelphia chromosome positive B-precursor ACUTE LYMPHOBLASTIC LEUKEMIA (Ph+ ALL), according to the results of a phase II study published in the Journal of Clinical Oncology.

"These data demonstrate efficacy of single-agent blinatumomab in relapsed or refractory Ph+ ALL," wrote Giovanni Martinelli, MD, PhD, of the Institute of Hematology and Medical Oncology, S. Orsola University Hospital, Italy, and colleagues. The results suggest the agent has "a possible future role in Ph-like ALL and combination therapies with TKIs for this disease setting."

According to the study, patients with Ph+ disease have poor prognosis.
The addition of TKIs to therapy have improved outcomes; however, disease relapse is still a significant and challenging concern. A phase II study of blinatumomab showed that the drug had anti-leukemic activity in adults with Philadelphia chromosome­negative (Ph­) disease, and the agent received approval in this setting. With this analysis, Martinelli and colleagues wanted to evaluate its efficacy in patients with Ph+ disease.

The open-label study included 45 patients who received blinatumomab in 28-day cycles by continuous intravenous infusion. All patients had relapsed or were refractory to at least one second generation or later TKI or were intolerant to second-generation or later TKIs and intolerant or refractory to imatinib. The primary endpoint was complete remission or complete remission with partial hematologic recovery (CR/CRh) during the first two cycles of treatment.

Eighty-four percent of patients had received two or more prior TKIs. The median number of blinatumomab cycles was two. More than one-third (36%) of patients achieved the primary endpoint of the study, including 4 of 10 with T315I mutations. Fourteen of 16 patients achieving the primary endpoint achieved a complete response. Among those patients who responded, 47% had three or more prior TKIs and 35% had prior ponatinib.

"Notably, these data show that the proportion of patients who achieved CR/CRh was in line with that reported for less heavily pretreated populations or those in the Ph­ setting (36% vs 43% in Ph­ ALL), with similar or better response duration than that observed with TKI therapies," the researchers wrote.

The majority of patients (88%) who responded achieved a complete minimal residual disease response. Forty-four percent of patients who responded went on to allogeneic hematopoietic stem-cell transplantation, including 55% of transplant-naive responders.

With a median follow-up of 9 months, the median relapse-free survival was 6.7 months. No difference in relapse-free survival was seen for patients younger than 55 or older. With a median follow-up of 8.8 months, the median overall survival was 7.1 months.

"Adverse events were consistent with those previously observed for blinatumomab in the setting of relapsed or refractory Ph­ ALL," the researchers wrote.

There were no grade 4 or 5 adverse events. Three patients had cytokine release syndrome and three had grade 3 neurologic events.

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FDA APPROVES REGORAFENIB FOR LIVER CANCER

By Ian Ingram

The US Food and Drug Administration (FDA) has approved the oral, multi-kinase inhibitor regorafenib (Stivarga) for the second-line treatment of hepatocellular carcinoma (HCC), the first new drug for this disease in a decade, for patients who have previously received sorafenib.

"Limited treatment options are available for patients with LIVER CANCER," said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in a press release. "This is the first time patients with HCC have had an FDA-approved treatment that can be used if their cancer has stopped responding to initial treatment with sorafenib."

The approval of regorafenib was based on results of a randomized multicenter trial that included 573 HCC patients whose disease had progressed on sorafenib.  Patients in the trial received best supportive care plus either 160-mg oral regorafenib once per day or placebo for 21 days of a 28-day cycle. Patients were continued on regorafenib until disease progression or unacceptable toxicity.

Results of the trial showed that patients receiving regorafenib had an improvement in progression-free survival based on modified RECIST (hazard ratio [HR], 0.46; 95% CI, 0.37­0.56; P < .0001), with a median progression-free survival of 3.1 vs 1.5 months with placebo. Overall survival was also improved in patients on regorafenib (HR, 0.63; 95% CI, 0.50­0.79; P < .0001), with a median overall survival of 10.6 months vs 7.8 months with placebo.

The overall response rate based on modified RECIST was 11% vs 4% in favor of regorafenib.

The most common adverse events (> 20%) associated with the drug were asthenia, decreased appetite, diarrhea, dysphonia, elevated bilirubin, fever, hand-foot skin reaction, hypertension, infection, mucositis, nausea, pain, rash, and weight loss.

The recommended dose for regorafenib is 160 mg daily, taken in four 40-mg tablets, for the first 21 days of each 28-day cycle. It is recommended that the drug be taken after a low-fat meal.

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PROTON THERAPY REIRRADIATION SAFE, EFFECTIVE FOR RECURRET THORACIC TUMORS

By Dave Levitan

The use of reirradiation with intensity-modulated proton therapy (IMPT) yielded strong overall survival with limited toxicity in patients with thoracic tumors, according to a new study, potentially offering a new option in this patient population.

"Local recurrences and local failures are a challenge in LUNG CANCER, and they are common problems," said Jennifer Ho, MD, of MD Anderson Cancer Center in Houston, during a press briefing at the 2017 Multidisciplinary Thoracic Cancers Symposium in San Francisco. "Historically, patients have not had a lot of treatment options."

IMPT can target tumors very precisely, and deposit the entire radiation dose inside a tumor with no exit dose, potentially lowering the risk of toxicity to surrounding healthy tissue. Ho presented results of a retrospective study of 27 patients with thoracic tumors who underwent reirradiation with this method between 2011 and 2016 at MD Anderson; 81% of the patients had non­small-cell lung cancer (NSCLC), 81% had centrally located tumors, and they were treated with IMPT a median of 29.5 months after initial radiation therapy. The study's median follow-up period was
11.2 months.

The median overall survival was 18 months, and the 1-year overall survival rate was 54%. The median progression-free survival was 19.3 months, with a 1-year progression-free survival rate of 51%. The median duration of freedom from local failure was not yet reached, with a 1-year rate of 78%; the same was true of the median duration of freedom from locoregional recurrence, with a 1-year rate of 61%.

Importantly, Ho said there was minimal serious toxicity seen in the study, with no grade 4 or 5 adverse events. There were two grade 3 pulmonary adverse events (7%), and one of fatigue (4%); all other adverse events, including esophagitis, dermatitis, pain, and hemoptysis, were of grade 1 or 2. Other studies of reirradiation have found serious toxicity rates as high as 30%.

Patients who received a reirradiation dose of 66 Gy or higher had better outcomes than those who received a lower dose. The 1-year freedom from local failure was 100% above that threshold and 49% below it (P = .013); a similar result was seen with freedom from locoregional recurrence. For progression-free survival, the 1-year rate above 66 Gy was 76%, compared with 14% below that dose (P = .050). The 1-year overall survival rate was also higher, at 62% vs 46%, respectively, but this did not reach significance (P = .289).

"We conclude that IMPT is an excellent choice for reirradiation," Ho said. "It's safe and effective, and it could be particularly useful when giving radiation to more challenging tumors located in complex locations."

Pranshu Mohindra, MD, of the University of Maryland in Baltimore, moderated the news briefing, and he noted that 60 Gy is the current standard dose for primary radiation of locally advanced NSCLC. "To be able to deliver more than 60 Gy with such high safety is impressive," he said, adding that at the moment, only a handful of centers around the country are capable of delivering this type of radiation therapy.

Still, he said that these "findings offer hope for patients with the challenging and often incurable diagnosis of recurrent lung cancer."

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Until June...

And if you have any thoughts of how this newsletter could be improved, please email me directly, at Elaine@elainejesmer.com.

Elaine Jesmer

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