Re: [MOL] Ovarian Cancer [01139]
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Re: [MOL] Ovarian Cancer
Dearest Marty - my thoughts and prayers will be with you both today. God bless. Cori.
Martin Auslander wrote:
> Dear Lil,
>
> Will be showing this to OUr Oncologist today. Thank you dear lady. Will
> keep you informed.
>
> God Bless,
> marty auslander
>
> > Lillian wrote:
> >
> >
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> > American Society of Clinical Oncology 35th Annual Meeting
> > Day 2 - May 16, 1999
> >
> > Ovarian Cancer: Defining "Standard Front-Line Chemotherapy"
> >
> > Maurie Markman, MD
> >
> > Click Here to listen to an audio interview with Dr. Markman. Duration:
> > 4 min. 57 sec.
> >
> > In 1996, the Gynecologic Oncology Group (GOG) published the results of
> > a randomized Phase III trial that compared the then "standard
> > chemotherapy" regimen of cisplatin (75 mg/m2) plus cyclophosphamide
> > (75 mg/m2) to an experimental regimen of cisplatin (75 mg/m2) plus
> > paclitaxel (135 mg/m2 delivered over 24 hours). This landmark study
> > demonstrated that the paclitaxel-containing regimen resulted in a
> > major improvement in both progression-free and overall survival in
> > suboptimal residual advanced ovarian cancer. These results
> > significantly changed the management of this difficult malignancy.
> >
> > A consortium of investigators from Canada and Europe subsequently
> > confirmed the results of the GOG trial, demonstrating that a regimen
> > of cisplatin plus 3-hour infusional paclitaxel improved both
> > progression-free and overall survival in advanced ovarian cancer.
> > Unfortunately, this study also demonstrated that the combination of
> > cisplatin and 3-hour infusional paclitaxel resulted in a significantly
> > greater risk of clinically relevant peripheral neuropathy, compared
> > with the control arm in that study, cisplatin plus cyclophosphamide.
> >
> > Carboplatin/Paclitaxel vs Cisplatin/Paclitaxel in Advanced Ovarian
> > Cancer
> >
> > In an effort to reduce the toxicity of therapy for advanced ovarian
> > cancer (eg, emesis, peripheral neuropathy) and develop a regimen that
> > can be easily administered in the outpatient setting, investigators
> > have explored the combination of carboplatin and paclitaxel. The
> > results of 2 large multicenter randomized trials that compared this
> > 2-drug combination chemotherapy regimen to a program of cisplatin plus
> > paclitaxel were reported on the second day of the 35th annual ASCO
> > conference.
> >
> > Dr. R. Ozols[1] reported the preliminary results of a GOG trial (GOG
> > 158) conducted in optimal residual stage III ovarian cancer (ie,
> > largest residual tumor nodule within the peritoneal cavity </=1cm in
> > maximum diameter) comparing carboplatin (AUC 7.5) plus paclitaxel (175
> > mg/m2 administered over 3 hours) to a control regimen of cisplatin (75
> > mg/m2) plus paclitaxel (135 mg/m2 over 24 hours). Both regimens were
> > administered on a 21-day schedule for 6 courses. Approximately one
> > third of the 840 patients entered into this trial had no gross
> > residual tumor at the initiation of chemotherapy.
> >
> > With a median follow-up of 19 months, there is no difference in either
> > progression-free or overall survival between the 2 treatment arms. As
> > might have been anticipated, nausea and vomiting and metabolic
> > abnormalities were more frequent in the cisplatin-containing arm, and
> > thrombocytopenia more frequent in the carboplatin-containing arm.
> > Grade 4 neutropenia was also more common in the cisplatin program.
> > There was no significant difference between the programs with regard
> > to the incidence of grade 2-3 neurotoxicity, perhaps reflecting the
> > relatively high dose of carboplatin (AUC 7.5) in combination with
> > 3-hour paclitaxel employed in the trial.
> >
> > There was also no difference in overall survival between the treatment
> > arms, although the total number of events does not permit a definitive
> > statement regarding survival at this point in time. However, as of
> > this date, overall survival is actually slightly (but not
> > significantly) in favor of the carboplatin-containing regimen.
> > Therefore, it is extremely unlikely that there will be any difference
> > between the regimens in favor of cisplatin.
> >
> > The GOG investigators concluded that the combination of carboplatin
> > and paclitaxel is the preferred treatment program due to its more
> > favorable toxicity profile and ease of administration. They recommend
> > that this regimen be considered standard of care in the treatment of
> > advanced ovarian cancer.
> >
> > In the second study, Dr. A. du Bois,[2] reporting for the AUG Study
> > Group, described the follow-up of 798 patients with advanced ovarian
> > cancer treated on a trial comparing cisplatin (75 mg/m2) plus
> > paclitaxel (185 mg/m2 over 3 hours) to carboplatin (AUC 6) plus
> > paclitaxel (185 mg/m2 over 3 hours). Treatment was repeated on a
> > 21-day schedule. With a median follow-up of 100 weeks, there has been
> > no difference in either progression-free or overall survival.
> >
> > The toxicity of the carboplatin-based regimen (specifically emesis and
> > neurotoxicity) was shown to be significantly less than that observed
> > with cisplatin. Grade 3-4 emesis was 7% in the carboplatin regimen
> > compared with 19% in the cisplatin regimen. Grade 3-4 neurotoxicity
> > was 8% and 19% in patients treated with carboplatin and cisplatin,
> > respectively. Formal quality-of-life analysis results were also in
> > favor of the carboplatin-based regimen. The authors concluded that
> > carboplatin-paclitaxel is the preferred regimen for the treatment of
> > advanced ovarian cancer, based on a more favorable toxicity profile.
> >
> > Carboplatin/Paclitaxel vs Cisplatin, Doxorubicin, Cyclophosphamide
> >
> > A preliminary report of data from a large (N=2074) multinational
> > study[3] comparing carboplatin-paclitaxel to a control arm of either
> > single-agent carboplatin or CAP (cisplatin, doxorubicin,
> > cyclophosphamide) was presented at Sunday's gynecology session of
> > ASCO.
> >
> > Carboplatin was given at an AUC of 5 with paclitaxel administered at a
> > dose of 175 mg/m2 over 3 hours. In the CAP regimen, the doses were
> > cisplatin 50 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500
> > mg/m2. Of the patients in this trial, 20% had stage 1 or 2 disease,
> > 65% had stage 3 disease, and 15% had stage 4 disease. Patients were
> > able to receive approximately 85% of the planned cycles of therapy,
> > regardless of the randomized regimen.
> >
> > With a median follow-up of only 18 months, the investigators were
> > unable to observe any difference between the study arms with regard to
> > progression-free or overall survival for the entire group. However,
> > subset analysis revealed a trend for improved survival in those
> > patients with larger bulk disease treated with the carboplatin
> > regimen.
> >
> > Dr. W. McGuire[4] cited the latter subset analysis results as good
> > reason not to conclude that this was a "negative" trial in terms of
> > the clinical utility of a combination carboplatin/paclitaxel regimen.
> > He also suggested that population differences between countries could
> > help explain the differences between the results of ICON-3 and the
> > previously noted GOG and Canadian-European studies, which found a
> > major advantage of cisplatin/paclitaxel over
> > cisplatin/cyclophosphamide in advanced ovarian cancer.
> >
> > Cisplatin/Cyclophosphamide vs Intraperitoneal P-32 in High-Risk
> > Early-Stage Ovarian Cancer
> >
> > Dr. R. Young,[5] reporting for the GOG, described the results of a
> > randomized trial comparing intraperitoneal P-32 with cisplatin (100
> > mg/m2) plus cyclophosphamide (1000 mg/m2), delivered on a 21-day
> > schedule for 3 courses, in high-risk early-stage ovarian cancer. A
> > total of 251 patients, of whom 205 were evaluable, were entered into
> > this trial. With a median follow-up of 6 years, the investigators
> > found a borderline statistically significant impact (P=.075) on
> > progression-free survival associated with the chemotherapy regimen
> > (31% reduction in risk of recurrence) but no effect on overall
> > survival.
> >
> > There was an important influence of stage on 5-year survival (stage I,
> > 77%; stage II, 65%), which was not influenced by treatment. Toxicity
> > overall was reasonable in both arms of the study, but there were more
> > bowel problems associated with intraperitoneal P-32, and some patients
> > experienced difficulty with isotope distribution. As a result of the
> > somewhat more favorable toxicity profile and modest impact on
> > progression-free survival, the investigators concluded that
> > cisplatin-based chemotherapy should be considered the standard
> > treatment option in patients with high-risk ovarian cancer receiving
> > chemotherapy.
> >
> > References
> >
> > 1. Ozols RF, Bundy BN, Fowler J, et al. Randomized Phase III Study
> > of Cisplatin (CIS)/Paclitaxel (PAC) Versus Carboplatin
> > (CARBO)/PAC in Optimal Stage III Epithelial Ovarian Cancer (OC):
> > A Gynecologic Oncology Group Trial (GOG 158) [Abstract 1373].
> > American Society of Clinical Oncology, 35th Annual Meeting,
> > Atlanta, 1999.
> > 2. DuBois A, Lueck HJ, Meier W, et al. Cisplatin/Paclitaxel Vs
> > Carboplatin/Paclitaxel in Ovarian Cancer: Update of an
> > Arbeitsgemeinschaft Gynaekologische Onkologie (AGO) Study Group
> > Trial [Abstract 1374]. American Society of Clinical Oncology,
> > 35th Annual Meeting, Atlanta, 1999.
> > 3. Harper P, on behalf of the ICON Collaborators. Cancer Division,
> > MRC Clinical Trials Unit, Cambridge, UK. A Randomised Comparison
> > of Paclitaxel (T) and Carboplatin (J) Versus a Control Arm of
> > Single Agent Carboplatin (J) or CAP (cyclophosphamide,
> > Doxorubicin and Cisplatin): 2075 Patients Randomised Into the 3rd
> > International Collaborative Ovarian Neoplasm Study (ICON3)
> > [Abstract 1375]. American Society of Clinical Oncology, 35th
> > Annual Meeting, Atlanta, 1999.
> > 4. Young RC, Brady MF, Nieberg RM, et al: Randomized clinical trial
> > of adjuvant treatment of women with early (FIGO-IIA high risk)
> > ovarian cancer [Abstract 1376]. American Society of Clinical
> > Oncology, 35th Annual Meeting, Atlanta, 1999.
> >
> > Return To Day 2 Stories
> >
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