Joy in the hospital again-need advice

Hi everyone, I am very sorry to report that Joy is in the hospital again. She has been in so much pain that radiates from her lower abdomen to around her back and down her thighs. She was in so much pain yesterday morning and so out of it, I took her to the ER and then they admitted her to give her some pain control. They did a CBC which was normal, the liver panel isn't back yet, but on last Tuesday it was all good. She has a low grade fever so they are doing some cultures. They will do an ultrasound today to see if she needs to be tapped again. But she's not looking too distented. I was wondering if any of you wonderful people have any thoughts on what this pain could be coming from. Is it just "cancer pain" which is what one nurse said last night? I don't really understand that. Is it radiating from her liver? Could it be caused by Ixempra? I know no one really knows just hoping for something to get her through this, she's so tired and thin.

One more question, her onc is hesitant to use Avastin, I think because some of the recent reports out there, but so many women seem to have good luck with it and it seems more tolarable than Ixempra? Any thoughts?

Thank you all so much I will give her all your love! Jennifer

[Sheila]

Jennifer
So sorry to hear about Joy being back in the hospital...hopefully they can isolate the cause of the pain. As far as the Avastin, it works well but does carry alot of side effects. It is usually given with Tykerb or herceptin and another chemo like Taxol....it might be too much on her body right now. It sounds like the Ixempra was working according to her latest labs...now if she can get over the fluid buildup and the leg pain. Tell her she is in my prayers and in my heart...she is such a fighter! Please tell her to stay strong and focused in this difficult setback.

[WomanofSteel]

I couldn't even begin to guess what the cause of Joy's pain is, but I am sorry she is back in the hospital. I hope she is out of pain and feeling better quickly. Joy is in my prayers.

[Hopeful]

Jennifer,

Thanks for this update. Please tell Joy she is in my thoughts (as are you). I have no idea what the pain could be, but have the doctors ruled out something neurological? Legs and back sound like sciatica, but I don't know that it would tie to the abdomen. Intuitively I would guess something pressing on a nerve but I am not a medical professional and that is just a guess.

Best of luck to you both,

Hopeful

[Joe]

Side Effects of Iexempra: Abdominal pain is one of them.

The following adverse reactions are discussed in greater detail in other sections.

• Peripheral neuropathy [see Warnings and PRECAUTIONS]
• Myelosuppression [see Warnings and PRECAUTIONS]
• Hypersensitivity reactions [see Warnings and PRECAUTIONS]

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.
Unless otherwise specified, assessment of adverse reactions is based on one randomized study (Study 046) and one single-arm study (Study 081). In Study 046, 369 patients with metastatic breast cancer were treated with IXEMPRA 40 mg/m2 administered intravenously over 3 hours every 21 days, combined with capecitabine 1000 mg/m2 twice daily for 2 weeks followed by a 1-week rest period. Patients treated with capecitabine as monotherapy (n=368) in this study received 1250 mg/m2 twice daily for 2 weeks every 21 days. In Study 081, 126 patients with metastatic or locally advanced breast cancer were treated with IXEMPRA 40 mg/m2 administered intravenously over 3 hours every 3 weeks.
The most common adverse reactions ( ≥ 20%) reported by patients receiving IXEMPRA were peripheral sensory neuropathy, fatigue/asthenia, myalgia/arthralgia, alopecia, nausea, vomiting, stomatitis/mucositis, diarrhea, and musculoskeletal pain. The following additional reactions occurred in ≥ 20% in combination treatment: palmar-plantar erythrodysesthesia (hand-foot) syndrome, anorexia, abdominal pain, nail disorder, and constipation. The most common hematologic abnormalities ( > 40%) include neutropenia, leukopenia, anemia, and thrombocytopenia.
Table 4 presents nonhematologic adverse reactions reported in 5% or more of patients. Hematologic abnormalities are presented separately in Table 5.

Table 4: Nonhematologic Drug-related Adverse Reactions Occurring in at Least 5% of Patients with Metastatic or Locally Advanced Breast Cancer Treated with IXEMPRA

Study 046 Study 081 IXEMPRA with
capecitabine
n=369Capecitabine
n=368IXEMPRA
monotherapy
n=126System Organ Classa/
Preferred TermTotal
(%)Grade 3/4
(%)Total
(%)Grade 3/4
(%)Total
(%)Grade 3/4
(%)Infections and Infestations Upper respiratory tract infection b4 0 3 0 6 0 Blood and Lymphatic System Disorders Febrile neutropenia54c11d33dImmune System Disorders Hypersensitivityb21d0051dMetabolism and Nutrition Disorders Anorexiab343d151d192dDehydrationb522< 1d21dPsychiatric Insomniab9< 1d2050Nervous System Disorders Peripheral neuropathy Sensory neuropathyb,e
Motor neuropathyb65 1621
5d16
< 10
062
1014
1dHeadache8< 1d30110Taste disorderb1204060Dizziness81d51d70Eye Disorders Lacrimation increased504< 1d40Vascular Disorders Hot flushb502060Respiratory, Thoracic, and Mediastinal Disorders Dyspneab714191dCoughb602020Gastrointestinal Disorders Nausea533d402d422dVomitingb394d242291dStomatitis/mucositisb314203d296Diarrheab446d399221dConstipati on2206< 1d162dAbdominal painb242d141d132dGastroesophageal reflux diseaseb71d8060Skin and Subcutaneous Tissue Disorders Alopeciab31030480Skin rashb171d7092dNail disorderb242d10< 1d90Palmar-plantar erythrodysesthesia syndromeb,f6418d6317d82dPruritus502061dSkin exfoliationb5< 1d3020Skin hyperpigmentationb11014020Musculoskeletal, Connective Tissue, and Bone Disorders Myalgia/arthralgiab398d5< 1d498dMusculoskeletal painb232d50203dGeneral Disorders and Administrative Site Conditions Fatigue/astheniab60162945613Edemab805< 1d91dPyrexia101d4081dPainb91d2083dChest painb41d< 1051dInvestigations Weight decreased1103060aSystem organ class presented as outlined in Guidelines for Preparing Core Clinical Safety Information on Drugs by the Council forInternational Organizations of Medical Sciences (CIOMS).
bA composite of multiple MedDRA Preferred Terms.
cNCI CTC grading for febrile neutropenia ranges from Grade 3 to 5. Three patients (1%) experienced Grade 5 (fatal) febrileneutropenia. Other neutropenia-related deaths (9) occurred in the absence of reported febrile neutropenia [see Warnings and PRECAUTIONS].
dNo grade 4 reports.
ePeripheral sensory neuropathy (graded with the NCI CTC scale) was defined as the occurrence of any of the following: areflexia,burning sensation, dysesthesia, hyperesthesia, hypoesthesia, hyporeflexia, neuralgia, neuritis, neuropathy, neuropathy peripheral,neurotoxicity, painful response to normal stimuli, paresthesia, pallanesthesia, peripheral sensory neuropathy, polyneuropathy,polyneuropathy toxic and sensorimotor disorder.
Peripheral motor neuropathy was defined as the occurrence of any of the following: multifocal motor neuropathy, neuromusculartoxicity, peripheral motor neuropathy, and peripheral sensorimotor neuropathy.
f Palmar-plantar erythrodysesthesia (hand-foot syndrome) was graded on a 1-3 severity scale in Study 046.

Table 5: Hematologic Abnormalities in Patients with Metastatic or Locally Advanced Breast Cancer Treated with IXEMPRA

Study 046Study 081 IXEMPRA with
capecitabine
n=369Capecitabine
n=368IXEMPRA
monotherapy
n=126Hematology ParameterGrade 3
(%)Grade 4
(%)Grade 3
(%)Grade 4
(%)Grade 3
(%)Grade 4
(%) Neutropeniaa3236923123Leukopenia (WBC)4116513613Anemia (Hgb)824162Thrombocytopenia532252a G-CSF (granulocyte colony stimulating factor) or GM-CSF (granulocyte macrophage stimulating factor) was used in 20% and 17% of patients who received IXEMPRA in Study 046 and Study 081, respectively.
The following serious adverse reactions were also reported in 1323 patients treated with IXEMPRA as monotherapy or in combination with other therapies in Phase 2 and 3 studies.
Infections and Infestations: sepsis, pneumonia, infection, neutropenic infection, urinary tract infection, bacterial infection, enterocolitis, laryngitis, lower respiratory tract infection
Blood and Lymphatic System Disorders: coagulopathy, lymphopenia
Metabolism and Nutrition Disorders: hyponatremia, metabolic acidosis, hypokalemia, hypovolemia
Nervous System Disorders: cognitive disorder, syncope, cerebral hemorrhage, abnormal coordination, lethargy
Cardiac Disorders: myocardial infarction, supraventricular arrhythmia, left ventricular dysfunction, angina pectoris, atrial flutter, cardiomyopathy, myocardial ischemia
Vascular Disorders: hypotension, thrombosis, embolism, hemorrhage, hypovolemic shock, vasculitis
Respiratory, Thoracic, and Mediastinal Disorders: pneumonitis, hypoxia, respiratory failure, acute pulmonary edema, dysphonia, pharyngolaryngeal pain
Gastrointestinal Disorders: ileus, colitis, impaired gastric emptying, esophagitis, dysphagia, gastritis, gastrointestinal hemorrhage
Hepatobiliary Disorders: acute hepatic failure, jaundice
Skin and Subcutaneous Tissue Disorders: erythema multiforme
Musculoskeletal, Connective Tissue Disorders, and Bone Disorders: muscular weakness, muscle spasms, trismus
Renal and Urinary Disorders: nephrolithiasis, renal failure
General Disorders and Administration Site Conditions: chills
Investigations: increased transaminases, increased blood alkaline phosphatase, increased gamma-glutamyltransferase.


DRUG INTERACTIONS

Effect of Other Drugs on Ixabepilone

Drugs That May Increase Ixabepilone Plasma Concentrations

CYP3A4 Inhibitors: Co-administration of ixabepilone with ketoconazole, a potent CYP3A4 inhibitor, increased ixabepilone AUC by 79% compared to ixabepilone treatment alone. If alternative treatment cannot be administered, a dose adjustment should be considered. The effect of mild or moderate inhibitors (eg, erythromycin, fluconazole, or verapamil) on exposure to ixabepilone has not been studied. Therefore, caution should be used when administering mild or moderate CYP3A4 inhibitors during treatment with IXEMPRA, and alternative therapeutic agents that do not inhibit CYP3A4 should be considered. Patients receiving CYP3A4 inhibitors during treatment with IXEMPRA should be monitored closely for acute toxicities (eg, frequent monitoring of peripheral blood counts between cycles of IXEMPRA). [See DOSAGE AND ADMINISTRATION]
Drugs That May Decrease Ixabepilone Plasma Concentrations

CYP3A4 Inducers: IXEMPRA is a CYP3A4 substrate. Strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifampicin, rifabutin, and phenobarbital) may decrease ixabepilone concentrations leading to subtherapeutic levels. Therefore, therapeutic agents with low enzyme induction potential should be considered for coadministration with IXEMPRA. St. John's Wort may decrease ixabepilone plasma concentrations unpredictably and should be avoided.
Effect of Ixabepilone on Other Drugs

Ixabepilone does not inhibit CYP enzymes at relevant clinical concentrations and is not expected to alter the plasma concentrations of other drugs [see CLINICAL PHARMACOLOGY].
Capecitabine

In patients with cancer who received ixabepilone (40 mg/m2) in combination with capecitabine (1000 mg/m2), ixabepilone Cmax decreased by 19%, capecitabine Cmax decreased by 27%, and 5-fluorouracil AUC increased by 14%, as compared to ixabepilone or capecitabine administered separately. The interaction is not clinically significant given that the combination treatment is supported by efficacy data.
Last updated on RxList: 10/23/2007

[chrisy]

Jen,
So sorry to hear Joy is having another setback - and I hope they can help manage her pain. I think of Joy daily, constantly actually.

I don't remember, has Joy had any recent scans? I thought there was an ultrasound or something but don't remember...I guess what I'm wondering is if there is any "visual" of what's going on in the abdominal area?

From what Joy has said, her oncologist seems very creative and knowledgeable - so the hesitation with Avastin is probably a thoughtful one. As Sheila noted, Avastin is usually given in combination with a chemo and her2 target therapy rather than alone as a single agent. And it is not without it's own side effects. Perhaps the reluctance is to ADD another thing to the mix. If the Ixempra is working, which seems a good possibility based on the markers, she may want to stay the course.

Jen, I know this must be very hard - to see your sister in pain and feel that there is little you can do to help. Please know that you are helping just by being there for her.

We all are praying for the best for Joy.

Much love
Chris

[Mary Anne in TX]

thank you Jennifer for passing on our love and concern to Joy. I do believe that the treatment could be the cause of the pain. I was so surprised at the severity of the pain I had with shingles for so long. It taught me that some things don't have to "seem logical" to be true. Best wishes to you both, ma

[Shobha]

So sorry to hear about Joy. I am holding Joy in my prayers and wishing her speedy recovery.

hugs,
shobha

[Lien]

Oh no! I'm so sorry for Joy and for you Jen, that you are facing another setback. I hope they find out what's causing the pain asap. Either that, or an effective means of killing the pain so she can continue to get benefits from Ixempra.

This is tough. I'm sending healing vibes. Maybe some unorthodox pain tx like acupuncture or foot reflexology might give her some relief? Acupuncture helped my mom deal with side effects from tx.

Love

Jacqueline

[Bill]

Jen, thanks for keeping us posted. I wish I could help. Tell Joy we said Hi and we're pulling for her. Joe might have pegged it. You all will be in my prayers.

[mamacze]

Oh Jen,I am sure the last thing Joy (or YOU) wanted was to land back in that hospital - UGH - but what else could you do when Joy clearly needs pain relief?

I have been puzzling and puzzling over the pain you describe; and these are my thoughts (being mindful that I am not an expert):

• I think Joe may really have pegged it as a side effect of Iexempra - especially if you click on the "Nephrolithiasis" Link.
• I remember my internist telling me that he often sees acute abdominal pain in his cancer patients starting new treatments - related to gall stones or kidney stones - it was his theory that the new chemo causes the body to try and eliminate "sludge" (for lack of a better word).
• I also remember feeling painful acute belly pain during my vaccine trial in Seattle - it came and went without dx, but there was conjecture that it could have been the liver mets or even kidney or gall stones interacting with the new treatment.
  

My over riding thought is for you and Joy. This is definitely a time for some chocolate; what else could help in such a painful moment.
Stay ever hopeful girls, you know our love and prayers are there for you to rest on.
Love and Hugs,
Kim from CT

[ElaineM]

I don't have any advice to offer, but please pass along my cyber hugs to Joy. She certainly needs a hug or two with all that is going on these days.

[harrie]

Jen, please give Joy my love and positive energy sent her way from me. I hope soon her pain and discomforts are contained.

[schoolteacher]

Jen,

Tell Joy I am thinking about her, and I hope she is feeling better. Thanks for letting us know how she is doing.

Amelia

[julierene]

I think about Joy every time I log in to this site! You've got my number if you or her want to call me. Avastin is what my onc wants to try next, with another med or two. But maybe some of these side-effects are from necrosis with her markers getting better? Did I read that right? Necrosis (scar tissue) is one of my largest culprits of pain. Necrosis also put me into the hospital with a low grade fever and abdominal pain so bad that I was doubled over trying to walk. When that happened to me, it was in December. Since then, they found something that started to work- an OLD treatment! I am almost in remission!!!! I was saying the same thing as Joy and thought I was on my way out. Tell her to keep trying new stuff if it's not working. If it's working, stay the course! Love, Julie

[Believe51]

Jennifer, I am so sorry to hear our girl is back in the hospital, but more sorry for how she is feeling. I have been extremely busy lately and need you to know that not to busy to keep this little woman in my prayers.

I must add that Ed appears to be doing well with his Ixempra and will be going for the second treatment on Friday. Although we are all different and experience different side effects I am hoping that Joy tolerates this drug as well. If not though, there are other options that can be explored.

With the team of Joy's caregivers, I have no doubt you are all doing your best, just like Joy is. Continued prayers and lots of love.>>Believe51

[Jean]

Jennifer,
Please tell Joy I am keeping her in my healing prayers,
I am glad you are with her you are a wonderful sister.

Blessing and hugs,
Jean

[Soccermom]

More prayers from me too,Jen...any updates since Tuesday?

Marcia

[Joan M]

Jennifer,

Please let Joy know she's in my prayers.

Joan

[mamacze]

I know you have your hands full; but I am thinking of Joy wondering how she is doing - any updates?
Love Kim from CT