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France extends moratorium on breast implants
Cancer responds better to combined treatments
Four studies of combined modality treatment presented at the annual meeting of the American Society of
trial, presented by Tom Miller (Tucson, USA), three cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) were combined with radiotherapy in a comparison with eight cycles of
Clinical Oncology (Philadelphia, May
CHOP in localised intermediate and
18-21) showed such differences. Muhyi Al-Sarraf (Southfield, USA) reported on a comparison of radio-
high-grade non-Hodgkin lymphoma. 5-year survival was 84% and 72%, respectively. The timing of surgery for breast cancer during the menstrual cycle
arge, clinically important effects
.Lfin randomised for
trials of treatments
poor-prognosis
cancers
are
rare.
versus radiotherapy plus chemotherapy in advanced nasopharyngeal cancer. 3-year survivals were 45% and 76% in 69 and 81 patients, respectively. These data are of the "highest significance we have ever seen", said Al-Sarraf. Arnold Herskovic (Dearborn, USA) presented a trial of radiotherapy versus chemotherapy combined with radiotherapy (62 and 61 patients, respectively), for oesophageal carcinoma.
therapy
Median survivals
were
9-3 and 14.1
months, respectively; overall 5-year survival was 0% and 30%. Michel Bolla (Grenoble, France), presented the findings of a randomised trial of 415 patients with locally advanced prostate cancer in whom radiotherapy or radiotherapy plus hormonal treatment with goserelin were compared. 5-year overall survivals were 56% and 78%, respectively. "This is the first time that such an approach gave a survival benefit that was statistically significant", said Bolla. In the fourth
remains controversial. Some studies have found an increased risk of recurrence if the operation is done during the follicular phase (0-14 days after onset of menses) compared with the luteal phase (days 14-30). Mark Levine (Kingston, Canada) showed data from a randomised trial of two chemotherapy regimens in premenopausal women with node-positive breast cancer. The study was not set up to look at the timing of surgery, but 29% of patients operated on during the luteal phase had a recurrence compared with only 19% of follicularphase patients (risk ratio 2-2). "Only a randomised trial will give a definitive answer to this debate", said Levine, but accruing the 800 or so patients required may not be easy because surgeons and patients tend to opt for a luteal-phase operation David McNamee
France extends moratorium Ministry of Health on May 14 that the its moratorium on silicone breast implants will conmarket until tinue approval conditions are reinforced. This decision has implications for the licensing of implantable medical devices in the he French
T announced
on
implants
tions (contracture, rupture, and bleedins bv aDoraisine oublished litfound a erature, and low but probable risk of connective tissue disease, and definite mechanical risks. Two recommendations were made in the report: firstly, the current scientific evidence does
has
explantation existing implants, but with implants women
European Community, says Frederic Fleurette, coordinator of the Nationale Agence pour le Developpement de 1’Evaluation Medicale report on silicone breast implants. Silicone gel-filled implants were restricted to use in controlled clinical trials in January, 1992, by the US Food and Drug Administration. In Europe, France took the strongest position by establishing a moratorium on such implants. ANDEM has now assessed the incidence of both connective tissue diseases and local complica-
breast
not
warrant
of
should be informed of the risks and clinically followed ; secondly, before the implants are marketed, the 1993 CE toxicological and clinical requirements for medical devices must be fully applied. In future, Fleurette says, medical-device evaluations must be standardised throughout the community to prevent similar situations arising with other devices. Jane
Bradbury
Two spinal fusion devices recommended for US approval n
23 an advisory committee the US Food and Drug Administration urged approval for two new devices to aid spinal fusion in patients with degenerative lumbar disk disease. But the panel asked the FDA to attach restrictions to the devices, including that the two manu-
toMay
facturers, Spine-Tech (Minneapolis, MN, USA) and Surgical Dynamics (a division of US Surgical), complete detailed post-marketing studies of patients for at least 5 years postimplantation. These are the first spinal fixation devices to go through a
rigorous pre-market testing
process
under revised FDA medical device rules. Spine-Tech said its BAK Interbody Fusion System had high fusion rates-about 70% in the 260 patients who made it to 2-year follow-up. The titanium, hollowed-out cylinder is placed in the disk space after laminectomy to encourage fusion. Patients mostly had procedures on L4/L5 or L5/S 1, and had not responded to 6 months of non-operative therapy. All had severe pain, mostly in the back, with some down the leg. SpineTech said that patients’ pain and function scores improved over time, and were better or comparable to historical controls taken from published studies on posterior and anterior lumbar interbody fusion over the past 20 years.
Surgical Dynamics’ study was designed similarly. Its Ray Threaded Fusion Cage is also positioned in the disk space, and filled with autologous graft material. The firm said that 92% of 200 patients had fusion at 24 months. Patients’ pain and functionality improved over time, and were better than the historical controls. Panelists asked both firms for histological data to show what grew inside the cages, saying that it might not be "good" bone; neither company could do so. Panel members also expressed concern about long term implantation. Neither device has a high rate of complications, but the Ray device seems to be subject to fracture in high stress cases, and the BAK device seems to have migration potential. The panel also insisted that both firms develop decision-making materials to be used jointly by patients and
physicians. Alicia Ault Barnett
1543
Four studies of combined modality treatment presented at the annual meeting of the American Society of
trial, presented by Tom Miller (Tucson, USA), three cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) were combined with radiotherapy in a comparison with eight cycles of
Clinical Oncology (Philadelphia, May
CHOP in localised intermediate and
18-21) showed such differences. Muhyi Al-Sarraf (Southfield, USA) reported on a comparison of radio-
high-grade non-Hodgkin lymphoma. 5-year survival was 84% and 72%, respectively. The timing of surgery for breast cancer during the menstrual cycle
arge, clinically important effects
.Lfin randomised for
trials of treatments
poor-prognosis
cancers
are
rare.
versus radiotherapy plus chemotherapy in advanced nasopharyngeal cancer. 3-year survivals were 45% and 76% in 69 and 81 patients, respectively. These data are of the "highest significance we have ever seen", said Al-Sarraf. Arnold Herskovic (Dearborn, USA) presented a trial of radiotherapy versus chemotherapy combined with radiotherapy (62 and 61 patients, respectively), for oesophageal carcinoma.
therapy
Median survivals
were
9-3 and 14.1
months, respectively; overall 5-year survival was 0% and 30%. Michel Bolla (Grenoble, France), presented the findings of a randomised trial of 415 patients with locally advanced prostate cancer in whom radiotherapy or radiotherapy plus hormonal treatment with goserelin were compared. 5-year overall survivals were 56% and 78%, respectively. "This is the first time that such an approach gave a survival benefit that was statistically significant", said Bolla. In the fourth
remains controversial. Some studies have found an increased risk of recurrence if the operation is done during the follicular phase (0-14 days after onset of menses) compared with the luteal phase (days 14-30). Mark Levine (Kingston, Canada) showed data from a randomised trial of two chemotherapy regimens in premenopausal women with node-positive breast cancer. The study was not set up to look at the timing of surgery, but 29% of patients operated on during the luteal phase had a recurrence compared with only 19% of follicularphase patients (risk ratio 2-2). "Only a randomised trial will give a definitive answer to this debate", said Levine, but accruing the 800 or so patients required may not be easy because surgeons and patients tend to opt for a luteal-phase operation David McNamee
France extends moratorium Ministry of Health on May 14 that the its moratorium on silicone breast implants will conmarket until tinue approval conditions are reinforced. This decision has implications for the licensing of implantable medical devices in the he French
T announced
on
implants
tions (contracture, rupture, and bleedins bv aDoraisine oublished litfound a erature, and low but probable risk of connective tissue disease, and definite mechanical risks. Two recommendations were made in the report: firstly, the current scientific evidence does
has
explantation existing implants, but with implants women
European Community, says Frederic Fleurette, coordinator of the Nationale Agence pour le Developpement de 1’Evaluation Medicale report on silicone breast implants. Silicone gel-filled implants were restricted to use in controlled clinical trials in January, 1992, by the US Food and Drug Administration. In Europe, France took the strongest position by establishing a moratorium on such implants. ANDEM has now assessed the incidence of both connective tissue diseases and local complica-
breast
not
warrant
of
should be informed of the risks and clinically followed ; secondly, before the implants are marketed, the 1993 CE toxicological and clinical requirements for medical devices must be fully applied. In future, Fleurette says, medical-device evaluations must be standardised throughout the community to prevent similar situations arising with other devices. Jane
Bradbury
Two spinal fusion devices recommended for US approval n
23 an advisory committee the US Food and Drug Administration urged approval for two new devices to aid spinal fusion in patients with degenerative lumbar disk disease. But the panel asked the FDA to attach restrictions to the devices, including that the two manu-
toMay
facturers, Spine-Tech (Minneapolis, MN, USA) and Surgical Dynamics (a division of US Surgical), complete detailed post-marketing studies of patients for at least 5 years postimplantation. These are the first spinal fixation devices to go through a
rigorous pre-market testing
process
under revised FDA medical device rules. Spine-Tech said its BAK Interbody Fusion System had high fusion rates-about 70% in the 260 patients who made it to 2-year follow-up. The titanium, hollowed-out cylinder is placed in the disk space after laminectomy to encourage fusion. Patients mostly had procedures on L4/L5 or L5/S 1, and had not responded to 6 months of non-operative therapy. All had severe pain, mostly in the back, with some down the leg. SpineTech said that patients’ pain and function scores improved over time, and were better or comparable to historical controls taken from published studies on posterior and anterior lumbar interbody fusion over the past 20 years.
Surgical Dynamics’ study was designed similarly. Its Ray Threaded Fusion Cage is also positioned in the disk space, and filled with autologous graft material. The firm said that 92% of 200 patients had fusion at 24 months. Patients’ pain and functionality improved over time, and were better than the historical controls. Panelists asked both firms for histological data to show what grew inside the cages, saying that it might not be "good" bone; neither company could do so. Panel members also expressed concern about long term implantation. Neither device has a high rate of complications, but the Ray device seems to be subject to fracture in high stress cases, and the BAK device seems to have migration potential. The panel also insisted that both firms develop decision-making materials to be used jointly by patients and
physicians. Alicia Ault Barnett
1543