Study: shark cartilage is not useful for lung cancer patients

Reference

lu C, Lee JJ, Komaki r, et al. Radiochemotherapy with or without AE-941 with non-small lung cancer in stage III: a randomized phase III study. j Natl Cancer Inst. 2010; 102 (12): 859-865.

Design

Multicentric, randomized, double-blind, placebo-controlled phase III study. Between June 5, 2000 and February 6, 2006, 379 patients with unresolved non-small cell lung cancer (NSCLC) were recorded in stage III. All patients received chemotherapy, including a platinum -based active ingredient, and radiation therapy. The patients were randomized in a ratio of 1: 1 and received either 120 ml ae-941 (neovastat) (n = 188) or an equal dose of placebo (n = 191) orally twice a day. The groups were stratified according to the stage (IIIA or IIIB), chemotherapy scheme and gender. The assessment of the tumor status by means of computer tomography (CT) took place at the beginning of the course, before the thorax radiation therapy (which started on the 50th day) and 6 weeks after radiation therapy. The primary endpoint was overall survival. The secondary endpoints included the time until progression (TTP), progression -free survival (PFS), the tumor response rate and toxic effects.

most important knowledge

There was no statistically significant difference in the overall survival in patients who had AE-941 income, compared to placebo: 14.4 months (95 %KI = 12.6–17.9 months) vs. 15.6 months (95 %KI = 13.8–18.1 months). Even with no secondary endpoints of the study, there was a statistically significant difference between the AE-941 and the placebo group. Mediane TTP = 11.3 months (95 %-KI = 9.0–16.8 months) in AE-941 vs. 10.7 months (95 %-KI = 9.5–21.6 months) in the placebo group. Similar results were achieved for progression -free survival.

effects on practice

The use of shark cartilage as an alternative cancer treatment has been advertised in lay media for many years. In 1992 William Lane Haie received no cancer: How shark cartilage could save her life what with a product he sold, shark cartilage extract (benefit). The use of shark cartilage is an interesting story about the best and worst aspects of marketing and developing natural active ingredients. While a product was sold on the market, a large part of the scientific community rejected its use due to exaggeration and lack of evidence. Meanwhile, the Canadian pharmaceutical company Aeterna Zentaris, owner of AE-941 (neovastat), looked for its cancer-inhibiting effect.

until 2003 AE-941 seemed to be a very promising active ingredient, and data increased to its cancer-inhibiting effects in vitro and in vivo . This included a study from 2002 to advanced cancer, which showed that a cohort of patients with kidney cell cancer (n = 22) in the group with high dose (240 ml/day) compared to the group with low dose (60 ml/day) showed an improved survival rate (16.1 vs. 7.1 months). ^{1 Annual conference of the American Society of Clinical Oncology (ASCO) in 2003, however, showed that there was no advantage for overall survival if there was a sole remedy for patients with kidney cancer who did not respond to immunotherapy.}

The current study, which is much more extensive and better controlled than all previously published studies, now provides enough evidence to refute the use of shark cartilage in patients with NSCLC and to dampen any enthusiasm for his use as anti -cancer.

The current study. . . delivers sufficient evidence to refute the use of shark cartilage.

AE-941 is a standardized, water-soluble shark cartilage extract. The exact composition of the extract is not announced, but there is a suspicion that proteins are responsible for its activity. in vitro, It has been shown that it induces the apoptosis of endothelzellen, inhibits matrix metalloproteinases and inhibits the vascular endothelial growth factor. ^{3.4.5 orally administered on a mouse, it showed an anti-tatic activity.}

This is cheap in vitro and in vivo The data led to an open dose escalation study of the phase I-II, in which AE-941 (30, 60, 120 and 240 ml/day) was examined in 80 patients with NSCLC. In this small study there was a statistically significant improvement in the survival rate in patients with NSCLC in stage III/IV (n = 48) who received the higher doses. The average survival time for the high dose group was 6.1 months compared to 4.6 months in the low dose group ( p = 0.26).

The current phase III study on NSCLC is much larger and better controlled than the pilot study. Although the recruitment was stopped before the desired sample size of 756 patients was reached, the final sample size of 384 patients was sufficient for statistical analysis. In the years 1, 3 and 5, the total survival rate in the AE-941 group was 59 %, 25 %and 14 %. In the placebo group, the total survival rates were 61 %, 21 %and 14 %after 1, 3 and 5 years. Even secondary endpoints did not lead to statistical benefits. This multicenter study included both academic and municipal clinics and was well controlled and designed.

As a practitioner, it is important that we remain up to date with new information about natural active ingredients, which are attributed to a cancer -inhibiting effect. We should neither have the mass press influence nor reject ideas before all evidence is evaluated. Hair cartilage is an example of a promising product in vitro This simply has not proven itself in large clinical studies. Although it is still sold on the market, there is not enough evidence to justify its use, and there is evidence that directly refute its use at NSCLC. Of course, the dietary supplement also affects the haipopulation ecologically, which, given its widespread use, represents a separate but justified concern. The National Cancer Institute offers a .

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