15 december 2011: onderstaand enkele studies die aan tonen dat chemo na operatie de ziektevrije tijd kan verlengen van blaaskankerpatiënten. Maar lees ook in linkerkolom over andere aanpak met minder toxische middelen.

d.d. 13 november 2003:

Chemo vooraf aan operatie geeft langere gemiddelde overleving ( 46 maanden t.o. 77 maanden P=0.06) dan alleen operatie voor lokaal gevorderde blaaskanker, aldus 11 jarige gerandomiseerde studie bij resp. 153 (met chemo vooraf) t.o. 154 patiënten (zonder chemo vooraf) en de uitkomsten op gemiddelde overleving vergeleken met elkaar. Deze studie is gepubliceerd in The New England Journal of Medicin (Volume 349:859-866 August 28, 2003 Number 9). Eerst het Engelstalige abstract van deze studie en daaronder een commentaar, ook verschenen in de NJEM.  Daaronder hoe dezelfde studie door het NCI naar buiten wordt gebracht. Opvallend hoe resultaten uit een en dezelfde studie op verschillende manieren naar buiten worden gebracht. Maar oordeelt u zelf over de waarde van deze 'objectieve' berichtgeving.

Het blijkt namelijk dat als natuurlijke en andere doodsoorzaken meegeteld worden het verschil niet meer significant is.Na acht jaar waren in de groep met alleen operatie 100 sterfgevallen tegenover 90 in de combinatiegroep chemo-operatie. Daarbij aangetekend moet ook nog worden dat hoe ouder de patiënt bij aanvang van de behandeling hoe korter de overleving. De vraag is o.i ook, maar wij zijn geen onderzoekers en statistici hoe groot en significant het effect is geweest op de kwaliteit van leven. Wij vinden het wel jammer dat nooit eens daar een vergelijkend onderzoeksverslag mee gedaan wordt.

Neoadjuvant Chemotherapy plus Cystectomy Compared with Cystectomy Alone for Locally Advanced Bladder Cancer

H. Barton Grossman, M.D., Ronald B. Natale, M.D., Catherine M. Tangen, Dr.P.H., V.O. Speights, D.O., Nicholas J. Vogelzang, M.D., Donald L. Trump, M.D., Ralph W. deVere White, M.D., Michael F. Sarosdy, M.D., David P. Wood, Jr., M.D., Derek Raghavan, M.D., Ph.D., and E. David Crawford, M.D. 

ABSTRACT

Background Despite aggressive local therapy, patients with locally advanced bladder cancer are at significant risk for metastases. We evaluated the ability of neoadjuvant chemotherapy to improve the outcome in patients with locally advanced bladder cancer who were treated with radical cystectomy. 

Methods Patients were enrolled if they had muscle-invasive bladder cancer (stage T2 to T4a) and were to be treated with radical cystectomy. They were stratified according to age (less than 65 years vs. 65 years or older) and stage (superficial muscle invasion vs. more extensive disease) and were randomly assigned to radical cystectomy alone or three cycles of methotrexate, vinblastine, doxorubicin, and cisplatin followed by radical cystectomy. 

Results We enrolled 317 patients over an 11-year period, 10 of whom were found to be ineligible; thus, 154 were assigned to receive surgery alone and 153 to receive combination therapy. According to an intention-to-treat analysis, the median survival among patients assigned to surgery alone was 46 months, as compared with 77 months among patients assigned to combination therapy (P=0.06 by a two-sided stratified log-rank test). In both groups, improved survival was associated with the absence of residual cancer in the cystectomy specimen. Significantly more patients in the combination-therapy group had no residual disease than patients in the cystectomy group (38 percent vs. 15 percent, P<0.001). 

Conclusions As compared with radical cystectomy alone, the use of neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin followed by radical cystectomy increases the likelihood of eliminating residual cancer in the cystectomy specimen and is associated with improved survival among patients with locally advanced bladder cancer. 

Source Information

From the M.D. Anderson Cancer Center, Houston (H.B.G.); Cedars–Sinai Comprehensive Cancer Center, Los Angeles (R.B.N.); the Southwest Oncology Group Statistical Center, Seattle (C.M.T.); Scott and White Clinic, Temple, Tex. (V.O.S.); the University of Chicago Cancer Research Center, Chicago (N.J.V.); the University of Pittsburgh School of Medicine, Pittsburgh (D.L.T.); the University of California, Davis, Sacramento (R.W.D.W.); the University of Texas Health Science Center, San Antonio, San Antonio (M.F.S.); Wayne State University Medical Center, Detroit (D.P.W.); the University of Southern California School of Medicine, Los Angeles (D.R.); and the University of Colorado, Denver (E.D.C.). 

Address reprint requests to the Southwest Oncology Group (SWOG-8710) Operations Office at 14980 Omicron Dr., San Antonio, TX 78245-3217.

Commentaar van een arts verbonden aan de NEJM:

Chemotherapy before surgery improves survival from bladder cancer
Quebec David Spurgeon 

Patients who received chemotherapy before surgery for locally advanced bladder cancer lived an average of 31 months longer than patients treated with surgery alone, an 11 year study of 307 patients has shown (New England Journal of Medicine 2003;349:859-66). 

The principal investigator, Dr H Barton Grossman, professor of urology at the M D Anderson Cancer Center, University of Texas, Houston, said: "Treatment of this disease varies across the country, but we believe neoadjuvant chemotherapy should be used more frequently to treat patients with locally advanced bladder cancer." 

Patients in the study who were treated with surgery alone had a 66% greater chance of dying from bladder cancer than patients who had both treatments. 

Bladder cancer, a worldwide problem, is related to tobacco use. In the United States it is the fourth most common cancer in men and the eighth most common in women. The American Cancer Society says that about 57 000 people in the United States are expected to be given a diagnosis of bladder cancer in 2003 and that an estimated 12 500 people will die of it. 

Patients were enrolled in the study if they had muscle invasive bladder cancer (stage T2 to T4a) and were to be treated with radical cystectomy. They were stratified according to age (<65 years or >65 years) and stage of cancer (superficial muscle invasion or extensive disease) and were randomly assigned to radical cystectomy alone or three cycles of treatment with methotrexate, vinblastine, doxorubicin, and cisplatin, followed by radical cystectomy. 

Half the patients (154) patients were assigned to receive surgery alone and 153 to receive combination therapy. The median survival among patients assigned to surgery alone was 46 months, compared with 77 months among patients who had combination treatment (two sided stratified log rank test P=0.06). 

In both groups improved survival was associated with the absence of residual cancer in the cystectomy specimen. Significantly more patients in the combination treatment group had no residual disease (38%) than in the cystectomy group (15%) (P<0.001). 

"The chemotherapy effectively down-staged their cancer," said Dr Grossman. "Ten years after treatment, some of these patients are still alive, so neoadjuvant therapy before surgery provided a cure for them." 

When overall mortality was considered (death from any cause) the results were not as significant, said Dr Grossman. After eight years of follow up 90 patients in the combination treatment group and 100 patients in the surgery only group had died. This means that patients who only had surgery had a 33% greater chance of dying of any cause than patients who received combination treatment. Patients who died were generally older than patients who didn’t. 

d.d. 9 september 2003: 

Bron: NCI/GOV

Een gerandomiseerde trial onder 317 patiënten met blaaskanker waarbij de kanker nog niet doorgegroeid was in omliggend weefsel bewijst dat als de operatie van de blaas wordt voorafgegaan door een chemokuur met MVAC (methotrextate, vinblastine, doxorubicin en cisplatin) de overlevingstijd bijna verdubbelt . In de groep waarbij alleen de operatie werd uitgevoerd was de gemiddelde overlevingstijd 3,6 jaar tegenover 6,2 jaar in de groep patiënten die vooraf aan de operatie een chemokuur hadden gehad. De vijfjaarsoverleving was in de groep die chemo vooraf kreeg ook hoger dan in de groep die alleen operatie onderging, 57% tegenover 42%. Ook bewees de studie dat alleen chemo in een aantal gevallen een operatie niet noodzakelijk zou hebben gemaakt. Bij 37% van de patiënten die chemo ontvingen was geen klinisch bewijs van kanker meer te vinden en uit deze groep was de vijfjaarsoverleving 85%. Wel wordt opgemerkt dat de bij-effecten van de chemo varieerden van ernstig tot zeer ernstig, maar niemand was daaraan overleden en had geen effect op het slagen van de operatie, aldus de berichtgeving op de website van het NCI/GOV.

Chemotherapy before surgery nearly doubles survival rates in patients with locally advanced bladder cancer compared to surgery alone, according to a trial reported at the annual meeting of the American Society of Clinical Oncology in San Francisco on May 14, 2001. [Editor's note: final results from the study were later published in the August 28, 2003, issue of the New England Journal of Medicine.]

Locally advanced bladder cancer (Stage II-III) has spread from the lining the bladder into the wall of the organ, but has not yet invaded other organs. Cystectomy -- surgery to remove the bladder -- is the standard treatment, but often is not curative, said Ronald Natale, M.D., of Cedars-Sinai Comprehensive Cancer Center in Los Angeles, who reported on the trial.

The trial compared cystectomy alone to cystectomy preceded by three rounds of chemotherapy with MVAC (methotrexate, vinblastine, doxorubicin, and cisplatin), a standard treatment for bladder cancer. A total of 317 patients were randomly assigned to one approach or the other.

In the group receiving chemotherapy before surgery, median survival -- the point at which half of the patients are still alive -- was 6.2 years. In contrast, median survival was 3.6 years in the patients who had surgery without chemotherapy.

Five-year survival rates were also improved -- 57 percent for the chemotherapy group compared to 42 percent for the surgery-only group. The side effects of MVAC were moderate to severe but did not increase the number or severity of surgical complications. There were no chemotherapy-associated deaths.

The study also raised the possibility that chemotherapy may make surgery unnecessary in some patients. The investigators found no evidence of cancer in 38 percent of the patients who had received preoperative chemotherapy. And in this population of patients, the five-year survival was 85 percent.

This finding "provides a strong rationale for considering a bladder-sparing approach in future studies," Natale said. He also suggested that future studies might look at other chemotherapy regimens, such as the combination of cisplatin and gemcitabine, which has fewer side effects than MVAC and is now also considered a standard therapy.

However, both Natale and other experts cautioned that more study was needed to confirm the benefits of preoperative treatment. Cora Sternberg, M.D., of the Vincenzo Pansadoro Foundation, pointed out that the study was relatively small. As one of the experts asked to comment on the findings after they were presented, she also pointed out that seven previous studies had not been able to detect any benefit to this approach.

"The results of a single clinical trial…does not change the standard of care," said Natale. But, he added, "the striking results of this study require that patients should at least be informed that preoperative chemotherapy might significantly change their survival."

 

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