Re: [MOL] Ovarian Cancer [01136]
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Re: [MOL] Ovarian Cancer
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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