“Patients with advanced skin cancer will be disappointed with news that cost regulators are planning to bar ‘routine’ first-line access to Bristol-Myers Squibb’s Yervoy (ipilimumab) on the National Health Service in England and Wales.
“The National Institute for Health and Care Excellence (NICE) has published draft guidelines recommending that the skin cancer treatment only be used by the NHS for patients in clinical trials, because current evidence is lacking.
“The Institute has already endorsed Yervoy as a second-line treatment for advanced malignant melanoma, but says the evidence provided by B-MS fails to conclusively show the degree to which the drug can extend life in previously untreated patients when compared with current standard care.”
“A proposal by (National Health Service) NHS cost regulators to no longer back the second-line use of Tarceva (erlotinib) to treat relapsed non-small cell lung cancer (NSCLC) has angered the drug’s manufacturer Roche and will no doubt come as a shock to patients.
“Following a review of existing guidance, the National Institute for Health and Care Excellence (NICE) has decided that treatment with Tarceva after first-line therapy has failed is no longer a cost-effective option for the NHS.
“According to Roche, the move means that more than 1,000 patients in England and Wales every year will be at risk from being left without an active second-line treatment option.”
Skin rash is a common side effect of the lung cancer drug erlotinib (Tarceva). However, a clinical trialsuggests that this rash can be a good sign and can be used to guide dosing. One hundred twenty-four patients with advanced non-small cell lung cancer (NSCLC) received first-line treatment with Tarceva. The drug dose was gradually increased until patients developed a skin rash or other side effects that prevented further dose increases. Seventy percent of patients developed a skin rash. Patients who developed a skin rash survived longer than those who did not (6.8 months longer on average), even though they did not differ in how much the treatment reduced the growth of their tumors.
A combination of the drugs carboplatin (Paraplatin), paclitaxel (Taxol/Abraxane), cetuximab (Erbitux), and bevacizumab (Avastin) has demonstrated effectiveness against non-small cell lung cancer (NSCLC) in a phase II clinical trial. One hundred two patients with advanced non-squamous NSCLC received the four-drug combo as a first-line treatment. Tumors shrank in 56% of patients and stopped growing in an additional 21%. Patients went an average of 7 months without their cancer progressing; the average survival time was 15 months. Four treatment-related deaths occurred, including two due to hemorrhage (heavy bleeding), which can be a rare but serious effect of Avastin treatment. This side effect profile was within the predefined safety margin. A phase III trial further investigating this drug combination for NSCLC is currently enrolling participants.
While medical research has produced significant treatment innovations for many cancer types, so far little has changed for small cell lung cancer (SCLC). Current treatment guidelines recommend chemotherapy with etoposide (Etopophos) and cisplatin (Platinol), drugs than are more than 30 years old. Relapse is common, and survival rates remain low. Now, the new PINNACLE clinical trial will investigate a new drug against SCLC. Patients with extensive-stage SCLC who have never received any other cancer treatment will be treated with Etopophos and Platinol either by themselves or in combination with the new drug, OMP-59R5. The drug acts by inhibiting NOTCH, a protein involved in cell development and growth that plays a role in various cancers. For more information, call 646-888-4203.
Combining cetuximab (Erbitux), bevacizumab (Avastin), and traditional chemotherapy in patients with non-small cell lung cancer (NSCLC) appeared to be safe and effective in a phase II clinical trial. Patients with advanced non-squamous NSCLC received Erbitux and Avastin in addition to carboplatin (Paraplatin) and paclitaxel (Taxol/Abraxane) as first-line treatment, followed by maintenance treatment with Erbitux and Avastin. Tumors shrank in 56% of patients and stopped growing in an additional 21%. Serious side effects were relatively rare; the rate was comparable to that of either Erbitux or Avastin alone. Both Erbitux and Avastin have shown efficacy in NSCLC by themselves, but may be more effective when given together. An ongoing phase III clinical trial will further investigate this drug combination.
Afatinib (Gilotrif) is a new lung cancer drug for people with non-small cell lung cancer (NSCLC) who have mutations in the EGFR gene. The LUX-Lung 3 clinical trial demonstrated that Gilotrif is superior to chemotherapy as first-line treatment in a global population of patients with EGFR-mutant NSCLC. The LUX-Lung 6 trial confirmed these findings specifically in an Asian population; Asia has a three times higher rate of EGFR-mutant NSCLC than Western countries. More recent evidence indicates that Gilotrif is as effective in patients with rare EGFR mutations as it is in those with common mutations. Finally, Gilotrif recently showed effectiveness in NSCLC patients whose cancer had spread to the brain.
The recent PointBreak clinical trial compared two treatment regimens for non-squamous non-small cell lung cancer (NSCLC). Previously untreated patients with advanced non-squamous NSCLC received initial treatment with carboplatin (Paraplatin), bevacizumab (Avastin), and either pemetrexed (Alimta) or paclitaxel (Taxol/Abraxane). The Alimta-treated group was then given maintenance treatment with Alimta and Avastin, while the other patients received Avastin only. Alimta treatment was associated with slightly longer times until the cancer progressed again (average 6.0 months, compared to 5.6 in the Alimta-free regimen). However, overall survival did not differ between the groups. The two regimens differed in what specific side effect were most common, but had similar overall toxicities and were generally tolerable.