New FDA Approvals for Lung Cancer, Myeloma

FDA Approves Crizotinib for ROS1 Rearranged Advanced NSCLC:

The US Food and Drug Administration (FDA) has announced its approval of crizotinib (Xalkori) for the treatment of patients with non–small-cell lung cancer (NSCLC) and

ROS1

rearrangements. Research has shown that

ROS1

rearrangements are estimated to occur in about 1% of patients with NSCLC. The FDA based its approval on efficacy data taken from a single-arm study of crizotinib in 50 patients. The study assigned patients with advanced disease to an oral dose of 250 mg crizotinib twice daily. The objective response rate according to RECIST v1.0, as evaluated by independent radiology review, was 66% (95% CI, 51–79). Three patients had a complete response to therapy and 33 had partial responses. Image © muratart / Shutterstock.com

FDA Approves Melphalan Formulation for Multiple Myeloma:

The US Food and Drug Administration has approved Captisol-enabled melphalan (Evomela) for two indications in multiple myeloma-as a palliative treatment for multiple myeloma patients for whom oral therapy is not appropriate and for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (HSCT). The trial that led to the approval was a multicenter, open-label, phase IIb study that included 61 patients. The overall response rate to the drug was 100%, with a complete response rate of 21%, according to an independent review. Melphalan is already used in the treatment of multiple myeloma, and is the primary drug in conditioning therapy prior to HSCT. The new formulation does not contain propylene glycol and is stable at room temperature for 4 hours in addition to the 1 hour following reconstitution.

Childhood Chemotherapy Had Little Effect on Female Survivors Becoming Pregnant:

Women who were treated with chemotherapy for a childhood cancer still had a good chance of becoming pregnant later in life, according to the results of a new analysis. However, male survivors treated with certain chemotherapy drugs, such as cyclophosphamide or cisplatin, had a decreased likelihood of siring a pregnancy compared with healthy siblings, the study showed. Only treatment with busulfan (HR = 0.22; P = .02) or doses of lomustine at 411 mg/m² or greater (HR = 0.41; P = .046) were linked with a lower likelihood of pregnancy among female survivors. Other alkylating and DNA interstrand crosslinking drugs were only associated with a decreased likelihood of pregnancy at very high cumulative doses. Image © Subbotina Anna / Shutterstock.com

BMI, Body Surface Area Predictive of Papillary Thyroid Cancer Characteristics in Women:

A retrospective cohort study showed that anthropometric parameters such as body mass index (BMI) and body surface area are predictive of certain behaviors of papillary thyroid carcinoma (PTC) including multiplicity and extrathyroidal extension (ETE) in women, but not in men. Among women, being overweight (BMI, 25 to 30 kg/m²) was an independent predictor of multiplicity, which was defined as two or more PTC lesions in a single lobe; the adjusted odds ratio (OR) was 1.187 (95% CI, 1.006–1.401;

P

= .042). Obesity (BMI ≥ 30 kg/m²) was more strongly associated with multiplicity, with an OR of 2.231 (95% CI, 1.590–3.129;

P

P = .012) and obesity (OR, 1.789 [95% CI, 1.188–2.692];

P

= .005) were also independent predictors of ETE in women. Image © Thongseedary / Shutterstock.com

Substantial Variation in Breast Biopsy Diagnoses for Atypia, DCIS Cases:

A new study found substantial diagnostic variability from pathologists when analyzing a single breast biopsy slide. Ductal carcinoma in situ (DCIS) and benign lesions with atypia tended to be “overinterpreted,” meaning the risk of the disease was overestimated. The new study involved an analysis of results from the B-Path (Breast Pathology) Study. When a single slide was used for invasive breast cancer diagnoses, verification was found to be highly probable. The diagnostic agreement just for this group was 97.7%. In contrast, the majority of diagnoses of atypia on a single slide would be overinterpretations by the pathologist. The reference panel would interpret 53.6% of these as benign without atypia, and 8.6% of them as DCIS. This disagreement remained high whether or not the pathologist considered the diagnosis borderline or asked for a second opinion.

Adding Ultrasound Best for Cancer Detection in Dense Breasts:

Ultrasound proved better than tomosynthesis at detecting breast cancer in women with dense breasts where mammography had not detected any cancer. Both modalities had a comparable false-positive rate, according to the interim results of the ASTOUND trial. Among 3,231 women with dense breasts where mammography had not detected any cancer, 24 addition cases of breast cancer were detected: 23 were invasive and 1 was non-invasive. Thirteen of the cases were detected with tomosynthesis compared to 23 detected by ultrasound imaging (

P

= .006). The incremental cancer detection rate (CDR) was 7.1 per 1,000 screens using ultrasound compared with a rate of 4 per 1,000 screens with tomosynthesis. The false-positive rate was 3.33% (107 participants), including 53 false-positive cases with tomosynthesis and 65 cases with ultrasound (

P

= .26). Image © Bork / Shutterstock.com

Negative Lung CT Could Lengthen Follow-Up For High-Risk Individuals:

People at high risk for lung cancer with a clean annual low-dose CT scan had a lower incidence of lung cancer and a lower risk of dying from lung cancer compared with all high-risk participants undergoing screening, according to the results of a study published in

Lancet Oncology

. Of the of 26,231 participants, 19,066 had a negative initial CT screen. These participants had significantly lower incidence of lung cancer compared with the full population of participants (371.88 vs 661.23 per 100,000 person-years) and were less likely to die of lung cancer, with a lung cancer–related mortality of 185.82 compared with 277.20 per 100,000 person-years. “These data,” the authors wrote, “suggest that annual screens after subsequent negative low-dose CT screens might not be needed.” Image © bendao / Shutterstock.com

Lower Vitamin D Levels Predict Poor Survival Outcomes in Melanoma:

In patients with melanoma, lower 25-hydroxyvitamin D (vitamin D) levels were associated with poorer survival outcomes, according to a prospective study. This association was independent of C-reactive protein (CRP) levels. The study included 1,042 melanoma patients. On a multivariate analysis that adjusted for age, sex, disease stage, blood draw season, and CRP, vitamin D levels remained significantly associated with survival outcomes. The hazard ratio (HR) for overall survival (OS) was 1.02 per unit decrease of vitamin D (95% CI, 1.01–1.04;

P

= .005). Using 20 ng/mL as a clinical cutoff, those with deficient vitamin D levels had a significantly poorer OS than those above that mark, with an HR of 1.44 (95% CI, 1.13–1.85;

P

= .0036). The same was true for melanoma-specific survival, with an HR of 1.37 (95% CI, 1.00–1.87;

P

= .0475). Image © Australis Photography / Shutterstock.com