Phase III Study Combines SBRT and Sorafenib in Hepatocellular Carcinoma


Laura A. Dawson, MD, FRCPC, of Princess Margaret Cancer Centre, Toronto, and colleagues evaluated whether the addition of stereotactic body radiation therapy (SBRT) to sorafenib treatment might improve survival outcomes in patients with hepatocellular carcinoma. The results of this trial, presented during the 2023 American Society of Clinical Oncology (ASCO) GI Cancers Symposium (Abstract 489), suggest that SBRT improved both progression-free and overall survival compared with sorafenib alone and did not increase the frequency of adverse events.

The investigators focused on 177 patients with newly diagnosed or recurrent hepatocellular carcinoma who were deemed unsuitable for surgery or ablation. Participants were randomly assigned to receive sorafenib alone (n = 92) or following SBRT (n = 85).

The median patient age was 66 years, and 40% of patients had a single hepatocellular carcinoma. With a median follow-up of 13.2 and 33.7 months for all and living patients, respectively, 22% of individuals received SBRT after discontinuing sorafenib. There were 153 overall survival events, and the median overall survival was improved from 12.3 months with sorafenib alone to 15.8 months when combined with SBRT; median progression-free survival improved from 5.5 to 9.2 months (P = .0001).

Adverse events included eight cases of grade 3 or higher bleeding, affecting five patients and three patients in the sorafenib and SBRT-plus-sorafenib arms, respectively. Although prevalent, treatment-related adverse events of grade 3 or higher did not statistically differ between groups (42% vs. 47%). Adverse events of grade 5 included hepatic failure, lung infection, and death (n = 1 each). Of note, 35% of patients given SBRT plus sorafenib reported having an improved quality of life compared with 10% given sorafenib alone.

Source: JNCCN

Do drugs really have to be so expensive?.


A liver cancer treatment is off-limits in the NHS due to its unjustifiably high price tag, but in India the same treatment is available for less than £100 a month.

In this week’s Scrubbing Up, Michelle Childs, of Medecins Sans Frontieres, questions why wealthy nations are not doing more to drive down medicine costs.

Sorafenib tosylate is a drug for liver cancer patented by German pharmaceutical company Bayer and marketed as Nexavar.

Bayer priced the drug at nearly £3,500 per month.

Until March last year, India – a country where half the population live on less than £1 per day – had no choice but to pay this sum for patented Nexavar.

But to ensure its citizens had affordable access, the country has since granted a compulsory licence clause that cuts the cost of the drug by allowing another company to manufacture the therapy, even though it is still under patent.

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People in the UK today should be asking, ‘Why are these drug prices so high?’”

Michelle ChildsDirector of Policy and Advocacy at MSF’s Campaign for Access to Essential Medicines

This has slashed the price of the drug by an astounding 97% – generic versions of sorafenib in India cost around £84 per month.

In the UK, where an affordable generic version isn’t available, the price is around £3,000 per month, which drug regulators say is “simply too high” to justify making it available on the NHS.

Indeed, the watchdog NICE (National Institute for health and Clinical Excellence) rejected Nexavar for NHS use based on its cost-benefit calculation.

The reaction in the UK to this decision was swift and censorious. Health charities – including the heads of Macmillan Cancer Support and the British Liver Trust – cancer patients and their families all publicly slammed the decision, and some even went as far as to picket the NICE offices of CEO Andrew Dillon in protest. But the one place the anger wasn’t directed was at the prices set by the pharmaceutical companies.

With health budgets that need to be controlled and the Cancer Drugs Fund in the UK under pressure, the elephant in the room is the cost of the drug in the first place.

Why did no-one question Bayer on the price tag of its drug? Instead of asking, “Why are we refusing to pay for these high drug prices?”, people in the UK today should be asking, “Why are these drug prices so high?”

India did.

Bayer has said it will challenge India’s decision to allow the production of a cheaper generic copy of its patented drug.

It justifies the higher price of sorafenib saying it needs the revenue to pay for future innovation. But Bayer has refused to provide details on how much it invested in Nexavar’s research and development, the cost of which was partly subsidised by the US government.

The only figure Bayer was prepared to refer to was the $1 billion general R&D price tag that GSK Chief Andrew Witty recently called “one of the great myths of the industry”.

It is true that innovative new drugs can change the way we treat people and we need more of them.

But innovation is of little use if people cannot access new treatments because they are so expensive.

This has long been recognised as an issue in the developing world. Increasingly though, those who cannot afford these prices are in developed countries like the UK. The innovation system is failing.

A new approach is needed.

We need to move to a system where new drugs are priced as close to the cost of production as possible – and where innovation is paid for and rewarded separately. We need innovation and affordable access.

This is the prescription to address the needs of developing countries suggested by experts at the World Health Organization.

But the UK, EU and other developed countries are blocking meaningful progress.

With the UK, the US and the EU facing ageing populations and health budget blowouts, now is the time for them to start siding with developing countries on affordable access.

It is in the interests of everyone’s good health.

Source:BBC

 

palmar-plantar patchy callosities (PPPC)


Palmar-plantar erythrodysesthesia (PPE) is a time-honored term in clinical oncology that has found its way into textbooks and public dictionaries. It accurately describes a typical adverse effect of continuous-infusion fluorouracil, oral capecitabine, and other cytotoxic anticancer agents. With time, the descriptive term PPE has been replaced with the term hand-foot syndrome (HFS), which is preferred for its simplicity.

With the advent of the multikinase inhibitors sunitinib and sorafenib, a new type of dermatologic toxicity has been recognized. It consists of callosities (thickened callous skin) that are usually in patchy distribution on palms and soles, mostly located where skin is subjected to particular pressure or strain (heel, ball, or above joints), often painful, and sometimes ulcerated or blistering. This type of dermatitis has been called hand-foot-skin reaction (HFSR).1 Unfortunately, HFSR is being confused with HFS. Many oncologists have become negligent in this respect, calling any toxic dermatitis on the palms and soles HFS. This is clearly an undue medical simplification because the dermatitis induced by capecitabine is clearly different from the dermatitis induced by sunitinib or sorafenib both clinically and histologically and, most importantly, requires different dermatologic treatment.1 Dermatologists should help us distinguish the two conditions, perhaps by using time-honored descriptive terms such as PPE. What then could be a descriptive term for HFSR? Should we call it palmar-plantar patchy callosities (PPPC)?