Kidney Cancer Journal 33
MEDICAL INTELLIGENCE
Newsworthy, late-breaking information from Web-based
sources, professional societies, and government agencies
Avelumab + Axitinib Approved for Treatment of RCC
Avelumab (Bavencio) was approved for first-line treatment
of advanced renal cell carcinoma (RCC) in combination with
Axitinib (Inlyta), the FDA has announced. The agency based
the approval on data from the JAVELIN Renal 101 trial, a
randomized, multicenter, open-label trial of avelumab
combined with axitinib. The trial included 886 patients with
previously untreated advanced RCC who were randomly
assigned either to treatment with 10 mg/kg avelumab intravenous
infusion every two weeks plus 5 mg oral axitinib
twice daily or to treatment with 50 mg oral sunitinib once
daily for four weeks followed by two weeks off.
Researchers found that median progression-free survival
was 13.8 months for patients who received avelumab
plus axitinib and 8.4 months for patients who received
sunitinib. The FDA notes that the overall survival data were
immature, and at 19 months, the death rate was 27% in the
intent-to-treat population. Nine percent of patients experienced
grade 3 to 4 toxicity, which led to permanent discontinuation
in 7 percent. Seven percent of patients in the trial
had major cardiac adverse events.
Recommended dosing of avelumab is an intravenous
infusion of 800 mg every two weeks combined with 5 mg
oral axitinib twice daily. Commonly reported adverse reactions
with avelumab plus axitinib include diarrhea, fatigue,
hypertension, musculoskeletal pain, nausea, mucositis,
palmar-plantar erythrodysesthesia, dysphonia, decreased
appetite, hypothyroidism, rash, hepatotoxicity, dyspnea,
abdominal pain, and headache. The manufacturer’s labeling
information directs clinicians to inform patients of the risk
for pneumonitis, hepatitis, colitis, endocrinopathies, nephritis,
and renal dysfunction.
Epidemiology of RCC: New Snapshot of
Rates vs Other Cancers
The American Cancer Society has updated findings on
the epidemiology of all cancers, based on data from the
National Cancer Institute. The average age at diagnosis of
kidney cancer is 64. In 2019, it is estimated the US will see
73,820 new cases of kidney cancer (44,120 in men and
29,700 in women), and that nearly 14,700 individuals will
die from this disease.
Table 8. Five-year Relative Survival Rates* (%) by
Stage at Diagnosis, US, 2008-2014
All Local Regional Distant
stages
Breast (female) 90 99 85 27
Oral cavity & 65 84 65 3
pharynx
Colon & rectum 65 90 71 14
Ovary 47 92 75 29
Colon 64 90 71 14
Pancreas 9 34 12 3
Rectum 67 89 70 15
Prostate 98 >99 >99 30
Esophagus 19 45 24 5
Stomach 31 68 31 5
Kidney† 75 93 69 12
Testis 95 99 96 74
Larynx 61 78 46 34
Thyroid 98 >99 98 56
Liver‡ 18 31 11 2
Urinary bladder§ 77 69 35 5
Lung & bronchus 19 56 30 5
Uterine cervix 66 92 56 17
Melanoma of 92 98 64 23
the skin
Uterine corpus 81 95 69 16
*Rates are adjusted for normal life expectancy and are based on cases diagnosed
in the SEER 18 areas from 2008-2014, all followed through 2015.
†Includes renal pelvis. ‡ Includes intrahepatic bile duct. § Rate for in situ
cases is 95%. Local: an invasive malignant cancer confined entirely to the
organ of origin. Regional: a malignant cancer that 1) has extended beyond
the limits of the organ of origin directly into surrounding organs or tissues;
2) involves regional lymph nodes; or 3) has both regional extension and
involvement of regional lymph nodes. Distant: a malignant cancer that
has spread to parts of the body remote from the primary tumor either by
direct extension or by discontinuous metastasis to distant organs, tissues,
or via the lymphatic system to distant lymph nodes. Source: Noone AM,
Howlader N, Krapcho M, et al. (eds). SEER Cancer Statistics Review, 1975-
2015, National Cancer Institute, Bethesda, MD,
http://seer.cancer.gov/csr/1975_2015/, based on November 2017 SEER
data submission, posted to the SEER website April 2018.©2019 American
Cancer Society, Inc., Surveillance Research
Hispanic origin is not mutually exclusive from Asian/Pacific
Islander or American Indian/Alaska Native. *Rates are
per 100,000 population and age adjusted to the 2000 US
standard population and exclude data from Puerto Rico.
†Data based on Indian Health Service Contract Health
Service Delivery Areas. Source: Incidence – North American
Association of Central Cancer Registries, 2018. Mortality –
National Center for Health Statistics, Centers for Disease
Control and Prevention, 2018. ©2019 American Cancer
Society, Inc., Surveillance Research
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