Tuesday, 20 March 2012

21 March: Not such a great day today at Peter Mac Hospital

I am sad today as I have received some unexpected news. I was called in for an early appointment, it was brought forward from the 28 March to today, 21 March. My Specialist wanted to discuss some of the issues I have been experiencing over the past 3 weeks. My health has not neen ideal and my pain levels have shifted into a new category. From time to time I have experenced tightness, but  more recently I have begun to use some basic pain killers. I had related this all to the effects of the Gastro and the UTI, but the specialist believes that it is only a partial explanation.

Based on preliminary examination of my CT scan yesterday, 20 March, it appears that the tumours are on the move again and that it is time for me to look at my next treatment regime. Again, a team from a variety of hospitals will discuss the best fit for the next round of treatment.

Over the next fortnight, they will investigate if the US drug can be obtained for me on compassionate grounds. It is called Pazopanib. This can be taken orally morning and night and may be a better next step, rather than go back to Chemotherapy straight away.

The next chemotherapy drug based on standard treatments in Australia is called Ifosfamide. This is a 'cousin' of the trial drug Palifosfamide that I may have already been given in the Trial. If that is the case, and I will never know, it may not have much extra benefit......

So, while this is happening, I will wait until the Sarcoma Nurse from Peter Mac contacts me to inform me about progress in obtaining this new tablet. My next appointment is now on 4 April at Peter Mac. They are keen to start me on the next treatment as soon as possible, and I also may be moving from Peter Mac back to the Mercy Hospital for Women where my journey began last year.

Ok, it's time to regroup, rethink, get my emotions sorted and move forward. Lots of emotion today, but I am OK, just unhinged and surprised, dismayed and disappointed.

I am having a beautiful glass of Pinot tonight please join me if you can,

Cheers,
Georgia

PS   Here is some info on PAZOPANIB:

Pazopanib Shows 3-Fold Improvement in Progression-Free Survival
Oncology & Biotech News
Published Online: Thursday, August 4th, 2011
Winette T. A. van der Graaf, MD, PhD

Data from a randomized clinical trial showed that patients with anthracycline-treated sarcomas had a 3-fold improvement in progression-free survival (PFS) with antiangiogenic agent pazopanib versus placebo.
Pazopanib treatment was associated with a median PFS of 4.6 months versus 1.5 months in the placebo group. The difference translated into a 69% reduction in the hazard for progression, as reported at last month’s ASCO meeting in Chicago.
“We may now conclude that, after decades of chemotherapy, we finally have a new drug for our patients with soft-tissue sarcomas,” said Winette T. A. van der Graaf, MD, PhD, a medical oncologist at Radboud University Nijmegen Medical Center in the Netherlands. “I think pazopanib can be added to the palette of potentially active drugs. It is also important that this benefit is not restricted to rare sarcomas but has been shown to be effective in more common types of sarcomas.”
The findings came from the international multicenter phase III PALETTE trial involving patients with soft-tissue sarcomas, including leiomyosarcoma, synovial sarcoma, and fibrohistiocytic and fibroblastic sarcomas. Much of the basis for the trial came from a phase II study of pazopanib, which showed a 12-week progression-free rate of 40% to 50% in patients with advanced soft-tissue sarcomas (J Clin Oncol. 2009;27:3127-3132).
“After decades of chemotherapy, we finally have a new drug for our patients with softtissue sarcomas.”
–Winette T. A. van der Graaf, MD, PhDPALETTE investigators at 72 centers in 13 countries enrolled patients treated with as many as 4 prior chemotherapy regimens, and all patients had prior anthracycline exposure but no prior treatment with antiangiogenesis agents. Patients were randomized 2:1 to pazopanib 800 mg/day or placebo and followed until progression, unacceptable toxicity, withdrawal of consent, or death. The primary endpoint was PFS, and secondary endpoints were overall survival, overall response rate, quality of life, and safety.
The final analysis included 369 randomized patients. The trial ended November 2010 with a median follow-up of 15 months.
Leiomyosarcoma accounted for more than 40% of the tumors, and about 70% of the patients had high-grade tumors at diagnosis. Aside from the required anthracycline exposure, the patients’ treatment history most often included ifosfamide (>70%), gemcitabine (35%), and docetaxel (30%). A majority of patients had received more than 2 lines of chemotherapy for advanced disease.
Analysis of the primary endpoint demonstrates a significant advantage in favor of pazopanib (P <.0001). The benefit was consistent across the 3 major histologic strata (leiomyosarcoma, synovial, and other), associated with hazard ratios of 0.19 to 0.36, all of which achieved statistical significance (P = .0002 to P <.0001).
The interim analysis of overall survival showed no significant difference between treatment groups, as the pazopanib arm had a median overall survival of 11.9 months compared with 10.4 months in the placebo group (P = .1782). van der Graaf said the final analysis of overall survival will occur before the end of the year.
Table. Best Overall Response
 Pazopanib
n = 239Placebo
n = 123
Partial response14 (6%)0 (0%)
Stable disease164 (67%)47 (38%)
Clinical benefit73%38%
Adapted from van der Graaf et al. J Clin Oncol. 2011;29(suppl; abstr LBA10002).Best overall response in the pazopanib arm included partial responses in 6% of patients and stable disease in 67%, resulting in a clinical benefit rate of 73%. In contrast, no patient in the placebo arm had an objective response, and 38% had stable disease (Table).
The median treatment duration was 16.4 months in the pazopanib arm and 8.1 months in the placebo group. Half of patients in the pazopanib group required treatment interruptions, and 37% had dose reductions. Nonetheless, the dose intensity was 96.3%.
Adverse events most commonly associated with pazopanib treatment included fatigue (65%), diarrhea (58%), nausea (54%), weight loss (48%), hypertension (41%), and anorexia (40%). Grade 3/4 adverse events were infrequent.
Some patients in the pazopanib arm had liver enzyme abnormalities, which were expected. The most common grade 3/4 liver events involved gamma-GT (12%). The abnormalities were reversible in all cases.
“With adequate monitoring and timely interventions, adverse events are manageable,” said van der Graaf.

--------------------------------------------------------------------------------
van der Graaf WT, Blay J, Chawla SP, et al. PALLETTE: a randomized, double-blind, phase III trial of pazopanib versus placebo in patients with soft-tissue sarcoma whose disease has progressed during or following prior chemotherapy—An EORTC STBSG Global Network Study (EORTC 62072). J Clin Oncol. 2011;29(suppl; abstr LBA10002).

3 comments:

  1. Have been thinking of you and wondering how things were going. Keep that chin up! Karen T

    ReplyDelete