ONCOLOGY UPDATES

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Ductal Carcinoma in Situ Is Not Cancer 

September 25, 2016—Chicago—Lesions called ductal carcinoma in situ (DCIS) possess enormous tumor heterogeneity and varying propensity for progression. They should not all be treated the same, and fail to meet the accepted definition of cancer.

This assertion was advanced in a talk presented at the 18th Annual Lynn Sage Breast Cancer Symposium, from September 22 to 25.

Shelley Eun-Sil Hwang, MD, MPH, of Duke University Medical Center, Durham, North Carolina, began by citing definitions of cancer that DCIS fails to meet:
• Cancer is characterized by uncontrolled cell division, and cell division in DCIS is confined
• Cancer destroys local tissue, and DCIS does not
• Cancer disseminates to distant sites, and DCIS does not

Dr. Hwang stated that common reasons for treating DCIS do not coincide with goals of breast cancer treatment. DCIS is often treated:
• To detect more DCIS
• To eradicate all microcalcifications
• To alleviate anxiety about breast cancer risk
The goals of treating breast cancer are:
• To reduce breast cancer morbidity
• To eliminate breast cancer mortality

Recurrence rates of DCIS have been declining
Over the past 30 years, DCIS has been on a decline, which is limited to women who do not undergo radiotherapy. This predilection for women who decline radiotherapy suggests that improvement in radiotherapy efficacy has not contributed to the decline.
The decline is partly due to:
• Screening detection
• Negative margins
• Adjuvant therapies
Improvements in radiological detection and pathological assessment may account for the decline.

Comparative survival outcomes 
In 2015, a study of 121,080 patients with DCIS from the Surveillance, Epidemiology, and End Results (SEER) registry from 1991 to 2010 was performed by Worni et al. Overall survival was higher for lumpectomy + radiation than for mastectomy (hazard ratio 0.79, 95% confidence interval 0.76 – 0.83, P < .001). Overall survival was lower for lumpectomy alone than for mastectomy (hazard ratio 1.17, 95% confidence interval 1.13 – 1.23, P < .001).

Three-year disease-specific survival was:
• 98.9% with lumpectomy + radiotherapy
• 98.5% with mastectomy alone
• 98.4% with lumpectomy alone

In 2015, excision alone was evaluated in a prospective clinical trial over a 12–year period. Cohort 1 was low- or intermediate-grade disease, 2.5 cm or smaller. Cohort 2 was high-grade disease, 1 cm or smaller. Twelve-year rates of developing local recurrence of DCIS or invasive carcinoma were 14.4% in cohort 1 and 24.6% in cohort 2 (P = .003). Twelve-year rates of local recurrence of DCIS or invasive carcinoma were 7.5% and 13.4%, respectively (P = .08).

The premalignant potential of atypical hyperplasia 
In 2014, Hartmann et al evaluated the premalignant potential of atypical hyperplasia. They found that 20% of 698 women developed breast cancer and 15% of that disease was invasive. A 2:1 ratio of ipsilateral to contralateral breast cancers were node-positive. The authors concluded that both atypical ductal and lobular hyperplasias portend risk of DCIS and invasive breast cancers, predominantly ductal, with two-thirds of moderate or high grade. The ipsilateral breast is at especially high risk of breast cancer in the first 5 years after atypia, but risk remains elevated long-term in both breasts.

Risk of breast cancer in atypical hyperplasia rises with the number of foci 
Absolute risk of cumulative incidence of invasive breast cancer and DCIS 5 – 25 years after a biopsy diagnosis of atypical hyperplasia was calculated in 2015 by Degnim et al. At 25 years, breast cancer risk was:
• One focus, 23.9%
• Two foci, 35.5%
• Three or more foci, 46.6%

Risk of breast cancer in lobular carcinoma in situ 
In 2015, King et al assessed breast cancer risk after a diagnosis of lobular carcinoma in situ from 1980 – 2009 in 1060 patients. Women who opted for chemoprevention were at 7% 10-year cumulative risk. Those who did not opt for chemoprevention were at 21% 10-year cumulative risk (P < .001).

The outcome of DCIS without surgery 
In 2015, Sagara et al reported on a population of 57,222 patients with DCIS from the SEER database from 1988 – 2011. Ninety-eight percent of patients underwent surgery and 2% did not. After 72 months, 1.0% of patients had died of breast cancer. Those who underwent surgery experienced a 10-year disease-free survival rate of 98.6%. Those who did not undergo surgery experienced a disease-free survival rate of 98.8%.

Molecular phenotypes of DCIS predict overall and invasive cancer recurrence 
In 2015, Williams et al predicted the rates of overall and invasive cancer recurrence with four phenotypes of DCIS over 120 months. Overall, 18.2% of 314 women experienced recurrence (11.2% DCIS, 7% invasive cancer). A 7.6% rate of recurrence at 5 years was observed with luminal A DCIS, vs 15.8% – 36.1% in other phenotypes.

The hazard ratios of overall recurrence on multivariable analysis were 5.14 for luminal B DCIS, 3.27 for HER2-positive breast cancer, and 3.27 for triple-negative disease vs luminal A DCIS.

DCIS score predicts 10-year risk of invasive cancer and DCIS local recurrence 
In 2014, Rakovitch et al assessed 10-year risk of local recurrence and invasive cancer according to DCIS score. Patients whose DCIS scored low were at less than half the risk of those whose DCIS scored in the intermediate range.

Active surveillance for DCIS 
Ryser et al have modeled cumulative mortality with active surveillance for DCIS. They have found that 100 – 200 patients need to be treated to avert one breast cancer death.

The Comparison of Operative vs medical Endocrine Therapy (COMET) for low-risk DCIS 
Dr. Hwang is the principal investigator of this 60-month randomized comparison, which will begin recruiting in 2017. Active surveillance + endocrine therapy will be compared with surgery ± radiotherapy + endocrine therapy.

Two-, 5-, and 7-year invasive cancer, and overall and disease-specific survival will be assessed, as well as patient-reported outcome measures.

Implications of usual care vs active surveillance for DCIS 

Usual care Active surveillance
34,000 lumpectomies <1% 10-year disease-specific mortality
23,000 patients receive radiotherapy
10,000 unilateral mastectomies
4000 bilateral mastectomies
20,000 patients receive endocrine therapy



Conclusions
• DCIS falls into a category of pathologic diagnoses that confer a high risk of invasive breast cancer
• Lesions labeled as DCIS possess enormous heterogeneity and varying propensities for progression
• Techniques for diagnosing invasive cancer need to be improved
• Active surveillance needs to be widely adopted to prevent the vast number of needless interventions for DCIS[/vc_column_text][vc_separator color=”custom” accent_color=”#f80000″][/vc_column][/vc_row][vc_row el_id=”article2″][vc_column][vc_column_text]

FDA Approves New Treatment for Metastatic Pancreatic Cancer

The US Food and Drug Administration (FDA) has approved the combination of irinotecan liposome injection (Onivyde) plus 5-fluorouracil and leucovorin for the treatment of patients with metastatic pancreatic cancer whose disease has progressed on gemcitabine-based chemotherapy. The drug is a nanotherapeutic that consists of irinotecan molecules encapsulated in a 100 mm liposome sphere.

The combination is the only FDA-approved therapy option available for progressive metastatic pancreatic cancer.

The FDA approval is based on the results of the open-label, phase III NAPOLI-1 trial. The combination of irinotecan liposome injection plus 5-fluorouracil and leucovorin resulted in a 1.9-month survival improvement compared with 5-fluorouracil and leucovorin alone (6.1 months vs 4.2 months; P = .014).

“This is an important day for patients facing pancreatic cancer,” said Andrea Wang-Gillam, MD, PhD, associate professor of medicine and clinical director of the GI Oncology Program at the Washington University School of Medicine, St. Louis, Missouri, in a press release. Dr. Wang-Gillaman was one of the investigators of the NAPOLI-1 study.

The irinotecan liposome injection arm of the study also demonstrated a progression-free survival advantage over the control arm (3.1 months vs 1.5 months).

There will be about 48,960 new cases of pancreatic cancer diagnosed in the United States in 2015, according to the National Cancer Institute, and about 40,560 deaths from the disease. Pancreatic cancer is often diagnosed at a later, advanced stage when it is difficult to treat and removal of the tumor is not possible.

The drug carries a black box warning about the risk of severe neutropenia and diarrhea.

The most common side effects, experienced in more than 20% of patients, were diarrhea, fatigue/asthenia, vomiting, nausea, decreased appetite, stomatitis, and pyrexia. The most common grade 3/4 laboratory abnormalities, occurring in more than 10% of patients, were lymphopenia and neutropenia. Death from sepsis was also reported in patients treated with Irinotecan liposome injection.

– See more at: http://www.cancernetwork.com/pancreatic-cancer/fda-approves-new-treatment-metastatic-pancreatic-cancer?GUID=16BEF25D-4D8E-456A-A153-70CFCE2A1ED0&XGUID=&rememberme=1&ts=23102015#sthash.KKmkxCXX.dpuf[/vc_column_text][vc_separator color=”custom” accent_color=”#f80000″][/vc_column][/vc_row][vc_row el_id=”article3″][vc_column][vc_column_text]

FDA Approves New Treatment for Metastatic Pancreatic Cancer

Nivolumab (Opdivo, Bristol-Myers Squibb Company) is the first immunotherapy to be available for use in the treatment of lung cancer. The drug has just been approved by the US Food and Drug Administration (FDA) for use in patients with advanced/metastatic squamous non–small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

This is an additional indication for nivolumab; the drug was approved last year for patients with unresectable or metastatic melanoma who no longer respond to other drugs.

The approval of the lung cancer indication comes 3 months ahead of schedule, the FDA noted in its release.

It also noted that lung cancer is the leading cause of cancer death in the United States, with an estimated 224,210 new diagnoses and 159,260 deaths in 2014. NSCLC is the most common type of lung cancer, affecting 7 out of 8 lung cancer patients, the agency noted.

The approval is supported by results from a clinical trial that was stopped early after showing a survival benefit — the manufacturer released this topline finding recently, but the clinical data have not yet been presented at a meeting or published. At the time, the company noted that that trial (known as CheckMate 017) was conducted in 272 patients with advanced or metastatic squamous cell NSCLC and that it was open label. Patients were randomly assigned to treatment with either nivolumab 3 mg/kg intravenously every 2 weeks or docetaxel 75 mg/m² intravenously every 3 weeks.

Now the FDA reveals that that trial was designed to measure overall survival (OS) and found that patients who received nivolumab lived 3.2 months longer than those who received docetaxel. In addition, the company now revealed that the median OS was 9.2 months in the nivolumab group (95% CI, 7.3 – 13.3) and 6 months in the docetaxel group (95% CI, 5.1, 7.3), showing a 41% reduction in the risk for death (hazard ratio, 0.59; 95% CI, 0.44 – 0.79; P = .00025).

This is the first time that an immunotherapy has shown a survival benefit in lung cancer, although there has been quite a bit of excitement at lung cancer meetings in the last 2 years over the potential for new immunotherapies in this disease, based on earlier findings.

Nivolumab is one of several new immunotherapies that act on the programmed death pathway — it is a PD-1 inhibitor, and this action blocks the body’s immune system from attacking cancerous cells, the FDA explained.

“The FDA worked proactively with the company to facilitate the early submission and review of this important clinical trial when results first became available in late December 2014,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approval will provide patients and healthcare providers knowledge of the survival advantage associated with nivolumab and will help guide patient care and future lung cancer trials.”

The agency noted that the safety and efficacy of nivolumab in the treatment of squamous NSCLC were supported by a single-arm trial of 117 patients. These patients had progressed after receiving a platinum-based therapy and at least one additional systemic regimen, and were then treated with nivolumab. The results show that 15% of patients had an objective response rate, showing either partial shrinkage or complete disappearance of the tumor. Among the 15% who responded, more than half (59%) had responses lasting for 6 months or longer.

The most common side effects of nivolumab are fatigue, shortness of breath, musculoskeletal pain, decreased appetite, cough, nausea, and constipation. The most serious side effects are severe immune-mediated side effects involving healthy organs, including the lung, colon, liver, kidneys, and hormone-producing glands, the agency noted.

LUNGevity Foundation, a nonprofit organization, welcomed the approval of this “extraordinary” new drug with statements from two of its scientific advisory board members.

This is just the tip of the iceberg.

“Immunotherapy is transforming the lung cancer treatment paradigm, providing the most promising option yet in the second-line treatment for squamous cell lung cancer patients,” said Julie Brahmer, MD, thoracic cancer director at the Johns Hopkins Kimmel Cancer Center and associate professor of oncology at Johns Hopkins in Baltimore. “There’s still work to be done to determine which immunotherapy can best help which patient and which treatment combinations are most successful. The results of the nivolumab trials show the critical importance of lung cancer research and the extraordinary power of collaboration of researchers, physicians, and patients. The concurrence of patient and research interests has expedited the process behind this treatment from basic research to clinical trials to the initial step toward immunotherapy existing as the primary treatment for lung cancer. This is just the tip of the iceberg.”

David Carbone, MD, PhD, director of the James Thoracic Center at The Ohio State University in Columbus, concurs. “The revolutionary new field of immunotherapy has completely transformed the way we treat and understand the disease. While not a panacea for everyone, immunotherapy is a quantum leap for lung cancer treatments, and will only show more promise as research continues to unveil innovative and exciting ways to tap the potential of this therapy.”[/vc_column_text][vc_separator color=”custom” accent_color=”#f80000″][/vc_column][/vc_row][vc_row el_id=”article4″][vc_column][vc_column_text]

FDA Approves Opdivo to Treat Advanced Form of Kidney Cancer

The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy.

“Opdivo provides an important therapy option for patients with renal cell carcinoma,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It is one of few therapies that have demonstrated the ability to extend patients’ survival in treating this disease.” Torisel (temsirolimus), approved in 2007, is the only other FDA-approved therapy that has demonstrated overall survival in renal cell cancer.

Renal cell carcinoma is the most common form of kidney cancer in adults and forms in the tissues of the kidney that make urine. The National Cancer Institute estimates 61,560 new cases and 14,080 deaths from kidney and renal pelvis cancer in the United States this year.

“Additionally, Opdivo’s extended indication, from melanoma and non-small cell lung cancer to renal cell cancer, demonstrates how immune therapies can benefit patients across a wide range of tumors,” continued Dr. Pazdur.

Opdivo works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Opdivo may help the body’s immune system fight cancer cells. Opdivo is intended for use in renal cell carcinoma in patients who have received prior anti-angiogenic therapy (treatments that interfere with the blood vessels that contribute to the growth of cancerous cells).

The safety and efficacy of Opdivo for this use were demonstrated in an open-label, randomized study of 821 patients with advanced renal cell carcinoma whose disease worsened during or after treatment with an anti-angiogenic agent. Patients were treated with Opdivo or another type of kidney cancer treatment called everolimus (marketed as Afinitor). Those treated with Opdivo lived an average of 25 months after starting treatment compared to 19.6 months in those treated with Afinitor. This effect was observed regardless of the PD-L1 expression level of patients’ renal cell tumors. Additionally, 21.5 percent of those treated with Opdivo experienced a complete or partial shrinkage of their tumors, which lasted an average of 23 months, compared to 3.9 percent of those taking Afinitor, lasting an average of 13.7 months.

The most common side effects of Opdivo for this use are conditions relating to abnormal weakness or lack of energy (asthenic conditions), cough, nausea, rash, difficulty breathing (dyspnea), diarrhea, constipation, decreased appetite, back pain and joint pain (arthralgia).

Opdivo also has the potential to cause serious side effects that result from the immune system effect of Opdivo (known as “immune-mediated side effects”). These severe immune-mediated side effects involve healthy organs, including the lung, colon, liver, kidneys, hormone-producing glands and the brain.

The FDA granted the Opdivo application a breakthrough therapy designationfast track designation, and priority review status. These are distinct programs intended to facilitate and expedite the development and review of certain new drugs in light of their potential to benefit patients with serious or life-threatening conditions.[/vc_column_text][vc_separator color=”custom” accent_color=”#f80000″][/vc_column][/vc_row][vc_row el_id=”article5″][vc_column][vc_column_text]

FDA Approves Ramucirumab (Cyramza) for Gastric Cancer

The FDA has approved ramucirumab for treating gastric cancer and gastr…

The US Food and Drug Administration has approved the angiogenesis inhibitor ramucirumab (Cyramza) for the treatment of advanced gastric cancer and adenocarcinoma of the gastroesophageal junction. The new drug is intended as a second-line agent for patients with unresectable or metastatic disease following treatment with a fluoropyrimidine- or platinum-containing therapy.

The trial that led to the approval, the REGARD trial, was an international phase III trial that included 355 patients with unresectable or metastatic gastric or gastroesophageal junction cancer. Patients were randomized 2:1 to either treatment with ramucirumab (n = 238) or placebo (n = 117). The primary endpoint was overall survival.

Results of the trial found that patients who received treatment with ramucirumab saw an improvement in overall survival (5.2 months vs 3.8 months) and progression-free survival. In the REGARD trial, common adverse events experienced by patients in the ramucirumab arm included diarrhea and hypertension.

Results from another clinical trial, the RAINBOW trial, which studied the efficacy of ramucirumab plus paclitaxel vs paclitaxel alone, also showed an improvement in overall survival for patients treated with ramucirumab.

In 2014, an estimated 22,220 Americans will be diagnosed with gastric cancer and an estimated 10,990 will die from the disease, according to the National Cancer Institute.

“Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “[Ramucirumab is a] new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth.

– See more at: http://www.cancernetwork.com/gastrointestinal-cancer/fda-approves-ramucirumab-cyramza-gastric-cancer?GUID=16BEF25D-4D8E-456A-A153-70CFCE2A1ED0&rememberme=1&ts=25042014#sthash.YZqiCggc.dpuf[/vc_column_text][/vc_column][/vc_row]

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