Value-Based Cancer Care Issues


December 2011, Vol 2, No 7

Frontier Cancer Care in Montana on the Leading Edge of Patient Care

Best Practices

Interview with Patrick Cobb, MD, FACP

Advances in the translation of research into medical practice have improved the lives of many patients in the United States, particularly for those with cancer. In this interview, Dr Cobb describes the state-of-the-art cancer center that he and his colleagues opened last year to further transform care for patients with cancer in Montana and set an example for Cancer Clinics of Excellence.

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GPCI, or “GYPSY”: Calculated or Covert Cuts to Oncology Reimbursement

Robert “Bo” Gamble

Health Policy

Adear friend recently recanted to me some stories about her recent trip to Italy. One of her more memorable moments was bearing witness to a couple of young Gypsies slipping the wallets out of the pockets of some unsuspecting tourists. Within a nanosecond, cash and credit cards were gone. Thankfully, my friend saved the day by hurriedly calling attention to the heist, and theItalian polizia were quickly in pursuit.

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Dual HER2 Blockade with Pertuzumab Substantially Delays Disease Progression

Caroline Helwick

CTRC-AACR SABCS Annual Meeting

San Antonio, TX—It is becoming increasingly clear that 2 agents are better than 1 in treating HER2-positive advanced breast cancer.

The latest evidence comes from the results of the phase 3 clinical trial CLEOPATRA (Clinical Evaluation of Pertuzumab and Trastuzumab), which were presented at the 2011 CTRC-AACR/San Antonio Breast Cancer Symposium by Jose Baselga, MD, PhD, Professor of Medicine, Harvard Medical School and Associate Director of the Massachusetts General Hospital Cancer Center, Boston.

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Ruxolitinib First Drug Indicated for Myelofibrosis

FDA Approvals, News & Updates

Applying its priority review procedure, the FDA approved ruxolitinib (Jakafi, Incyte), an oral inhibitor of the Janus kinase (JAK) 1 and 2 gene, for the treatment of intermediate- and highrisk myelofibrosis (MF), including primary MF, postpolycythemia vera MF, and postessential thrombocythemia MF. Ruxolitinib is the first drug approved specifically for this indication. Ruxolitinib received accelerated approval (ahead of its regulatory date).

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FDA Updates OS Label Data for Bortezomib in Myeloma

FDA Approvals, News & Updates

The FDAapproved an update to the label of bortezomib (Velcade, Takeda) to include the newly reported 5-year OS data showing survival advantage when the drug is added to melphalan and prednisone (VMP) for patients with previously untreated multiple myeloma.

These longest available follow-up data for patients with myeloma show that patients who received the VMP regimen continued to have signif - icantly longer OS (median 56.4 months) than those who received the melphalan and prednisone regimen without bortezomib (median, 43.1 months).

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Role of Adjuvant Zoledronic Acid in Endocrine Receptor- Positive Breast Cancer Being Refined

Phoebe Starr

CTRC-AACR SABCS Annual Meeting

San Antonio, TX—Mounting evidence from randomized controlled trials suggests that zoledronic acid added to hormonal therapy will have its optimal use as adjuvant therapy in postmenopausal women with either medically/ surgically induced menopause or age-related menopause. The results of 2 trials were presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium.

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Adding Everolimus to Exemestane Significantly Prolongs Remission in Patients with Breast Cancer

Caroline Helwick

CTRC-AACR SABCS Annual Meeting

San Antonio, TX—Updated results from the phase 3 Breast Cancer Trials of Oral Everolinmus (BOLERO-2) showed that adding everolimus to the treatment regimen with the aromatase inhibitor exemestane more than doubles the time to disease progression in patients with advanced estrogen receptor (ER)-positive breast cancer whose disease has become refractory to hormonal therapy.

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New Prognostic Tool to Guide Treatment of Ductal Carcinoma In Situ

Caroline Helwick

CTRC-AACR SABCS Annual Meeting

San Antonio, TX—The treatment of ductal carcinoma in situ (DCIS)— breast cancer confined to the ducts—is a clinical challenge, as patients carry varying risks of recurrence and may easily be undertreated or overtreated. But Genomic Health, which markets Oncotype DX for assessing risk of recurrence in invasive cancers, has developed a similar test for DCIS that may prove useful for individualizing treatment in this subset of breast cancer. The test is expected to become available for physicians for use on December 28, 2011.

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Medical Staff Members Spend Many Hours Dealing with Insurance Companies

Caroline Helwick

Health Policy

Medical practices in the United States spend much more money and time dealing with third-party payers than do Canadian practices, according to a recent report (Morra D, et al. Health Aff. 2011;30:1443-1450).

The study showed that medical staff in the United States spend nearly 21 hours weekly dealing with insurance issues—addressing drug coverage, prior approvals, and other reimbursement issues—while their Canadian counterparts spend less than 3 hours weekly.

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Predictive Biomarker for Bevacizumab May Be Emerging

Audrey Andrews

ESMO 2011 Conference

Stockholm, Sweden—Investigators appear to be closer to identifying a biomarker that may predict response to bevacizumab (Avastin).

At the European Society for Medical Oncology’s 2011 European Multidisciplinary Cancer Congress, several presentations focused on baseline levels of a short isoform of the vascular endothelial growth factor (VEGF), plasma (p) VEGF-A. Thanks to a novel, highly sensitive enzyme-linked immunosorbent assay, this can now be measured.

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Delivering Affordable, Evidence-Based Cancer Care in High-Income Countries

Caroline Helwick

ESMO 2011 Conference

Stockholm, Sweden—A consortium of world cancer specialists, economists, and policymakers is tackling the issue of equitable cancer care in the face of rising cost of care in high-income countries. Their report (Sullivan R, et al. Lancet Oncol. 2011;12:933-980) coincided with a key presentation at the 2011 European Multidisciplinary Cancer Congress.

The report focused on the delivery of equitable and affordable care in the United States, Europe, Canada, Australia, and New Zealand.

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Young Patients Are Served Equally Well by Lumpectomy or Mastectomy

Caroline Helwick

ASCO Breast Cancer Symposium

San Francisco, CA—Breast cancer in women under age 40 years is often considered a more aggressive disease than in older women, and this often leads clinicians to recommend mastectomy over breast-conserving therapy (BCT), that is, lumpectomy or radiation. However, 2 studies presented at the 2011 Breast Cancer Symposium suggest that younger age in itself is not a reason for mastectomy.

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Letrozole More Effective than Tamoxifen in Postmenopausal Breast Cancer

In the Literature

The Breast International Group (BIG) 1-98 is a randomized, phase 3, double-blind clinical trial that includes 8010 postmenopausal women with early-stage hormone receptor–positive breast cancer. The current study reports the median 8.1-year follow-up outcomes of the BIG 1-98, reflecting the long-term risk for recurrence and death in this patient population (Regan MM, et al. Lancet Oncol. 2011; 12:1101-1108).

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Second-Generation TKIs Produce Faster Optimal Response than Imatinib in CML

In the Literature

The second-generation tyrosine kinase inhibitors (TKIs) dasatinib and nilotinib produce optimal cytogenetic response after 3 months of treatment in themajority of patients with chronic myeloid leukemia (CML) in the chronic phase, a much faster rate than the 12 to 18 months for the peaked response reported with imatinib (Jabbour E, et al. J Clin Oncol. 2011;29:4260-4266).

In 2 simultaneous phase 2 trials, 167 patients with newly diagnosed chronic-phase CML were randomized to nilotinib (N = 81) or to dasatinib (N = 86).

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Azacitidine Treatment Failure Outcomes in Patients with MDS or AML

In the Literature

Azacitidine is the current standard of care for high-risk myelodysplastic syndrome (MDS), but many patients experience treatment failure. No study has previously analyzed patient outcomes of those who fail azacitidine therapy. This new analysis combined data from 4 international clinical trials to describe patient outcomes after failing azacitidine treatment (Prébet T, et al. J Clin Oncol. 2011;29:3322-3327).

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High-Dose Radiation Does Not Improve Survival in Stage III NSCLC

Phoebe Starr

ASTRO Annual Meeting

Miami, FL—A regimen of high-dose radiation had no survival advantage over standard radiation with concurrent chemotherapy in patients with advanced unresectable non–smallcell lung cancer (NSCLC) that had spread to the lymph nodes, according to an interim analysis of a late-breaking study presented at the 2011 American Society for Radiation Oncology meeting.

The phase 3 RTOG 0617 trial showed that overall survival was 74% in the high-dose group versus 81% in the standard-dose arm, and median survival was 22 months versus 20 months, respectively.

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The Pace of Change in Oncology Management Greater than the Sum of Its Parts

Lee Goldberg

Oncology

Innovative medications target the molecular structure of cancer cells with increasing precision, resulting in reduced adverse effects. Novel therapies enlist the patients’ own immune systems to defeat cancer. At the same time, as personalized medicine comes of age, improved diagnostic tests match the right patients to these new treatments. The accelerating pace of these developments is improving expectations of patient survivability and the total number of survivors.

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Hypofractionated Radiotherapy in Prostate Cancer More Convenient for Patients

Phoebe Starr

ASTRO Annual Meeting

Miami, FL—Delivering higher doses of external-beam radiation over a shorter period (hypofractionated radiation) was as effective as conventional radiation in preventing treatment failure in men with intermediate- to high-risk prostate cancer. The hypofractionated regimen shortened treatment time by 2.5 weeks compared with conventional radiation. However, the frequency of grade 2 or higher genitourinary (GU) adverse events, particularly urinary incontinence, was much higher with the hypofractionated regimen in a phase 3 trial presented at the meeting.

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Is Sentinel Lymph Node Biopsy Truly the Standard of Care in Melanoma?

Rosemary Frei, MSc

American Pathologists Meeting

Grapevine, TX—Two expert oncologists presented the clinical data in support for and against the use of sentinel lymph node biopsy (SLNB) in melanoma as the standard of care during the 2011 College of American Pathologists annual meeting.

Vernon Sondak, MD, Chair, De - partment of Cutaneous Oncology, Moffitt Cancer Center, Tampa, FL, supported the use of SLNB as the standard of care in melanoma.

J. Meirion Thomas, MD, attending oncologist, Royal Marsden Hospital and Imperial College, London, said that routine SLNB in melanoma is unwarranted.
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Ruxolitinib a New Oral Option for the Treatment of Patients with Intermediate- or High-Risk Myelofibrosis Disorders

Rhonda Williams

Cancer Drugs

Myeloproliferative neoplasms (MPNs) are a group of closely related hematologic malignancies that arise from abnormal development and function of the body’s bone marrow cells. Primary myelofibrosis (PMF), polycythemia vera (PV), and essential thrombocythemia (ET) comprise the Philadel phia chromosome (Ph)-negative MPNs.1

Myelofibrosis (MF) can arise on its own, which is called PMF, or it can result from the progression of other MPNs, such as postpolycythemia vera MF (PPV-MF) and postessential throm - bocythemia MF (PET-MF).1

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